Pain, PostoperativePhase 4NCT05708521
Personalization of Opioid Prescription Following Orthognathic Surgery
A Phase 4 study testing Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery and Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery in people with Pain, Postoperative and Orthognathic Surgery, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative, Orthognathic Surgery, Opioid Use
- What is being tested?
- Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery and Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2023to 1 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing orthognathic surgery for the correction of dentofacial deformities. Included in the study will be patients who receive single-jaw surgery (i.e. BSSO [Bilateral Sagittal Split Osteotomy, a surgery of the lower jaw] only, or Lefort [osteotomy of the upper jaw] only), or those in the double-jaw surgery category (BSSO and Lefort).
- Patients undergoing a functional genioplasty who have an additional osteotomy included in their surgical plan (i.e. BSSO and/or Lefort).
- Patients undergoing cleft orthognathic surgery.
Who cannot join
- Patients who are under the age of 18 at the time of surgery
- Patients who are contraindicated to undergo elective surgery, including pregnant patients.
- Patients with a history of opioid use disorder.
- Patients on chronic opioids within the past month.
- Patients who have a contraindication for multimodal analgesia (e.g. renal injury precluding the prescription of NSAIDs).
- Patients with allergies to opioids, acetaminophen, and/or NSAIDs.
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- Patients receiving a surgically-assisted rapid palatal expansion (SARPE) surgery due to the different post-operative nature of the surgery.
- Patients who have previously undergone prior orthognathic (i.e. repeat surgery), non-cleft craniofacial surgery, or have previously experienced maxillofacial trauma due to the potential alterations in neural pain pathways.
- Patients undergoing an isolated functional genioplasty.
- Patients who are unable to consent to surgery and/or the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Post-Operative Pain Following Orthognathic Surgery With Personalized Opioid Prescription and Tapering Protocols
This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner.
The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders.
Read more
Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used.
The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.
Read the detailed description
This study aims to investigate the use of post-operative pain management following orthognathic surgery, with a focus on the use of opioid medication. Orthognathic surgery is a foundational surgery for the correction of dentofacial deformities, which requires osteotomies, rearrangement, and fixation of the facial bones into a new position. Participants are often placed into maxillomandibular fixation postoperatively, limiting the range of motion of the mandible. The surgical trauma provoked by the osteotomies, stripping of facial muscles, and swelling of the associated soft tissue envelope can result in significant post-operative pain in participants. This pain is one of the primary reasons participants are admitted following surgery for up to several days. Further complicating pain management for these participants is the maxillomandibular fixation, which reduces the ability of participants to verbally communicate with their nursing staff about their levels of pain.
Multimodal analgesia using a combination of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and opioid medications are the mainstay therapies for acute post-surgical pain. However, long-term opioid use can lead to opioid tolerance, due to various mechanisms, including receptor desensitization and downregulation. This can lead to persistent postoperative opioid use and opioid use disorder.
In Canada, the opioid crisis is on the rise in all provinces, driven by both illegal and prescription opioids. Most opioid-related deaths occurred in males between the ages of 30 to 39, with an overall increase in the use rate amongst younger age groups. Canada has the second highest rate of opioid prescription in the world, after the United States of America. The legitimate use of opioid analgesics in adolescents - who otherwise disapprove of illegal drug use - is independently associated with a 33% increased risk of opioid misuse in later life. Furthermore, persistent opioid use may be the most common complication after elective surgery. Currently, in our department, much like many other oral and maxillofacial surgical centers, there is a "standardized" prescription of opioids, such as hydromorphone, for all participants being discharged from the hospital. However, it is clear from the literature and anecdotal evidence that most participants do not require as much opioids as we currently prescribe.
In the last few years, there have been recent initiatives to personalize post-operative pain management in orthopedic joint replacement as well as spine surgeries. In these studies, the primary consideration for opioid dosing and frequency following discharge relies on the participants' opioid requirements while in the hospital. A tapering protocol and cessation timeline following discharge is tailored for each participant based on their in-patient opioid requirements to promote opioid prescription stewardship further. These studies demonstrated a reduction in post-operative opioid consumption, with no changes in perceived pain and participants' satisfaction.
This study aims to assess the postoperative analgesic efficacy, opioid requirement, and total analgesic requirements for participants undergoing orthognathic surgery with a personalized discharge opioid prescription and tapering protocol. The study will compare two groups of participants: one group will receive the standardized prescription plan of hydromorphone, while the other group will receive a personalized prescription plan. The control will receive a standardized discharge prescription of 2-4 milligrams of liquid hydromorphone taken orally every 4 hours as needed for pain, with a total prescription of 40 milligrams of hydromorphone. The experimental group will receive a personalized hydromorphone prescription and tapering protocol for the study group. This prescription will be inferred from the participant's last 24-hour in-patient requirement of opioids before being discharged. The personalized schedule is based on a modification of a prescription schedule for spine and orthopedic joint procedures derived by Dr. Edward Mariano's group at Stanford University's Department of Anesthesiology, Perioperative and Pain Medicine.
Data will be obtained from the pre-admission appointment, and in-patient records including the nursing medication administration record (MAR), intra-operative anaesthesia records, participants' questionnaires, and the first follow-up appointment at 2 weeks. Data collected will include the participant's age, weight, body mass index, sex, pertinent medical and psychiatric history, pre-surgical anxiety, type of orthognathic surgery, length of surgery, length of stay in the hospital, amount and frequency of analgesics taken by the participants while in-hospital, analgesic dosages prescribed to the participants on discharge, amount and frequency of analgesics taken by the participants for each day following discharge, remaining prescribed opioids at the 2-week follow-up appointment, and the participant's self-reported satisfaction and pain on the Defense and Veterans Pain Rating Scale (DVPRS) questionnaire. All patient questionnaires will be recorded via REDCap, a secure online data management software.
Subjects will be stratified into single jaw surgery (i.e. LeFort only, BSSO only, +/- FG), or double jaw (i.e. LeFort and BSSO +/- FG). A Mann-Whitney U Test will be utilized for statistical analysis, with significance assumed at p < 0.05. This study is important as it will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery and also help promote opioid stewardship.
- Conditions
- Pain, Postoperative, Orthognathic Surgery, Opioid Use, Patient Satisfaction, Opioid Use Disorder
- Being tested
- Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery, Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery
- Keywords
- Personalized Opioid Prescription, Opioid Tapering Protocol, Orthognathic Surgery, Post-Operative Pain, Patient Satisfaction
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgeryDrug
POP participants will be given a personalized opioid prescription with a tapering protocol based on their last inpatient 24-hour usage of opioids, obtained from the nursing medication administration record. Should a participant stay in the hospital for less than 24 hours (e.g. patient had an early discharge at 18 hours), the 24-hour in-patient opioid usage would be extrapolated from their total amount and frequency of opioid use. The participant will be provided with an instruction card with suggestions on how much opioid to take at various time points following discharge to safely taper their medication.
Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgeryDrug
SOP participants will be given a standardized dose of hydromorphone (2-4mg orally every 6 hours), and a total amount of 40mg. No further information is provided to them with regards to their pain medication and to tapering.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Prescription Group (SOP) | Active comparator | All participants assigned to the SOP group will be treated as per the current status quo, in which they are given the standardized analgesic prescriptions following discharge from the hospital consisting of:
1. Acetaminophen 975 mg orally every 6 hours for 7 days
2. Ibuprofen 600 mg orally every 6 hours for 7 days
3. Hydromorphone 2-4 mg orally every 6 hours as needed, with a total dispense amount of 40mg.
The participants are not given instructions on how to taper their hydromorphone medication, which is the current status quo in our department. Receives: Drug: Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery |
| Personalized Prescription Group (POP) | Experimental | All participants assigned to the POP group will receive pre-operative education on the medications that they will be given while they are inpatients and upon discharge, along with a pain medication card to aid their understanding. Medications upon discharge will be:
1. Acetaminophen 975mg orally every 6 hours for 1 week
2. Ibuprofen 600 mg orally every 6 hours for 1 week
3. Hydromorphone - Prescribed with a personalized schedule and tapering protocol based on the participant's last 24-hour in-patient use of opioids.
Participants in this arm will also receive tapering instructions as well as an education card to assist them with their tapering protocol upon discharge. Receives: Drug: Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction (%) of remaining unused opioid
The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement.
The remaining opioid is compared to their prescribed opioid to determine the relative amount of unused opioid measured as a percentage.
Measured: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
Absolute amount (milligrams) of remaining unused opioid
The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement.
The remaining opioid is compared to their prescribed opioid to determine the absolute amount of unused opioid measured in milligrams.
Measured: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
Secondary outcomes (4)
Overall satisfaction with post-surgical pain management at home
The participant's overall satisfaction with their post-surgical pain management at home as measured on the supplemental questions in the Defense and Veterans Pain Rating Scale questionnaire.
The scale measures the participants satisfaction by asking them to indicate a score from 0 to 10 for 4 items on how the pain: interferes with activity, interferes with sleep, affects overall mood, and contributes to overall stress.
A score of 0 indicates that the pain does not contribute or interfere with the aforementioned items (i.e. patient is very satisfied), while a score of 10 indicates significant contribution or interference (i.e. patient is very dissatisfied).
Measured: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication.
Mean duration of usage of opioids
The secondary outcome measure is the mean duration of usage of opioids measured in number of days used post-operatively.
Measured: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Total daily use of opioid by the participant
Measured as total morphine milli-equivalents (MME) per day from the questionnaire filled out by the participant. Information is cross-referenced with the total remaining opioid brought back at the follow-up visit.
Measured: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Average daily pain scores following discharge
The participant indicates their level of pain each time they take an analgesic medication following discharge from hospital. This is based on the Defense and Veterans Pain Rating Scale, where a score of 0 indicates no pain, while a score of 10 indicates that the pain is severe.
The average of the scores for each day is obtained and reported as the average daily pain score.
Measured: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start24 Apr 2023
- Primary completion30 May 2024
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of 2 parallel study arms and followed longitudinally. Their allocation to the study arms will be performed by using a random number generator, whereby if the number 0 arises, they are allocated to the control group, and if the number 1 arises, they are assigned to the experimental group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Alsabbagh, Nova Scotia Health Authority
- Investigators
- Amr Alsabbagh, DDS, Principal investigator, Dalhousie UniversityJean-Charles Doucet, DMD, MD, MSc, Study chair, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708521
- Sponsor's protocol ID
- 52007
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make the individual participant data (IPD) collected in this study available to other researchers. This decision was made to protect the privacy of the participants involved in the study and to ensure that their personal information is not shared without their consent. All data collected to be shared outside of the research team will be aggregated data for the purpose of publications.
Publications
Bousquet B, Green MA, Caillouette CN, Simon J, Padwa BL, Resnick CM. How Much Opioid Medication Do Patients Need After Orthognathic Surgery? J Oral Maxillofac Surg. 2022 Jul;80(7):1174-1182. doi: 10.1016/j.joms.2022.04.002. Epub 2022 Apr 7.
PubMed 35526579Macintyre PE, Quinlan J, Levy N, Lobo DN. Current Issues in the Use of Opioids for the Management of Postoperative Pain: A Review. JAMA Surg. 2022 Feb 1;157(2):158-166. doi: 10.1001/jamasurg.2021.6210.
PubMed 34878527Pathan H, Williams J. Basic opioid pharmacology: an update. Br J Pain. 2012 Feb;6(1):11-6. doi: 10.1177/2049463712438493.
PubMed 26516461Borgland SL. Acute opioid receptor desensitization and tolerance: is there a link? Clin Exp Pharmacol Physiol. 2001 Mar;28(3):147-54. doi: 10.1046/j.1440-1681.2001.03418.x.
PubMed 11207668Kaye AD, Jones MR, Kaye AM, Ripoll JG, Galan V, Beakley BD, Calixto F, Bolden JL, Urman RD, Manchikanti L. Prescription Opioid Abuse in Chronic Pain: An Updated Review of Opioid Abuse Predictors and Strategies to Curb Opioid Abuse: Part 1. Pain Physician. 2017 Feb;20(2S):S93-S109.
PubMed 28226333Belzak L, Halverson J. The opioid crisis in Canada: a national perspective. Health Promot Chronic Dis Prev Can. 2018 Jun;38(6):224-233. doi: 10.24095/hpcdp.38.6.02.
PubMed 29911818Miech R, Johnston L, O'Malley PM, Keyes KM, Heard K. Prescription Opioids in Adolescence and Future Opioid Misuse. Pediatrics. 2015 Nov;136(5):e1169-77. doi: 10.1542/peds.2015-1364.
PubMed 26504126Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.
PubMed 32584407Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
PubMed 24519537Tamboli M, Mariano ER, Gustafson KE, Briones BL, Hunter OO, Wang RR, Harrison TK, Kou A, Mudumbai SC, Kim TE, Indelli PF, Giori NJ. A Multidisciplinary Patient-Specific Opioid Prescribing and Tapering Protocol Is Associated with a Decrease in Total Opioid Dose Prescribed for Six Weeks After Total Hip Arthroplasty. Pain Med. 2020 Nov 7;21(7):1474-1481. doi: 10.1093/pm/pnz260.
PubMed 31710680Joo SS, Hunter OO, Tamboli M, Leng JC, Harrison TK, Kassab K, Keeton JD, Skirboll S, Tharin S, Saleh E, Mudumbai SC, Wang RR, Kou A, Mariano ER. Implementation of a patient-specific tapering protocol at discharge decreases total opioid dose prescribed for 6 weeks after elective primary spine surgery. Reg Anesth Pain Med. 2020 Jun;45(6):474-478. doi: 10.1136/rapm-2020-101324. Epub 2020 Mar 31.
PubMed 32238478Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Kukushliev VV, Sherman KA, Kurylo CM, Ortmann SD, Scheidt RA, Scheidt KB. Tapered Dose Postoperative Opioid Prescriptions Following Inpatient Total Hip and Knee Arthroplasty: Quality Improvement Study and Retrospective Review. J Arthroplasty. 2023 Feb;38(2):239-244. doi: 10.1016/j.arth.2022.08.043. Epub 2022 Sep 6.
PubMed 36075313Yajnik M, Hill JN, Hunter OO, Howard SK, Kim TE, Harrison TK, Mariano ER. Patient education and engagement in postoperative pain management decreases opioid use following knee replacement surgery. Patient Educ Couns. 2019 Feb;102(2):383-387. doi: 10.1016/j.pec.2018.09.001. Epub 2018 Sep 5.
PubMed 30219634Von Korff M, Saunders K, Thomas Ray G, Boudreau D, Campbell C, Merrill J, Sullivan MD, Rutter CM, Silverberg MJ, Banta-Green C, Weisner C. De facto long-term opioid therapy for noncancer pain. Clin J Pain. 2008 Jul-Aug;24(6):521-7. doi: 10.1097/AJP.0b013e318169d03b.
PubMed 18574361
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Post-Operative Pain Following Orthognathic Surgery With Personalized Opioid Prescription and Tapering Protocols
- ClinicalTrials.gov ID
- NCT05708521
- Acronym / sponsor ID
- 52007
- Conditions
- Pain, Postoperative, Orthognathic Surgery, Opioid Use, Patient Satisfaction, Opioid Use Disorder
- Keywords
- Personalized Opioid Prescription, Opioid Tapering Protocol, Orthognathic Surgery, Post-Operative Pain, Patient Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner.
The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders.
Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used.
The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.
Detailed description
This study aims to investigate the use of post-operative pain management following orthognathic surgery, with a focus on the use of opioid medication. Orthognathic surgery is a foundational surgery for the correction of dentofacial deformities, which requires osteotomies, rearrangement, and fixation of the facial bones into a new position. Participants are often placed into maxillomandibular fixation postoperatively, limiting the range of motion of the mandible. The surgical trauma provoked by the osteotomies, stripping of facial muscles, and swelling of the associated soft tissue envelope can result in significant post-operative pain in participants. This pain is one of the primary reasons participants are admitted following surgery for up to several days. Further complicating pain management for these participants is the maxillomandibular fixation, which reduces the ability of participants to verbally communicate with their nursing staff about their levels of pain.
Multimodal analgesia using a combination of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and opioid medications are the mainstay therapies for acute post-surgical pain. However, long-term opioid use can lead to opioid tolerance, due to various mechanisms, including receptor desensitization and downregulation. This can lead to persistent postoperative opioid use and opioid use disorder.
In Canada, the opioid crisis is on the rise in all provinces, driven by both illegal and prescription opioids. Most opioid-related deaths occurred in males between the ages of 30 to 39, with an overall increase in the use rate amongst younger age groups. Canada has the second highest rate of opioid prescription in the world, after the United States of America. The legitimate use of opioid analgesics in adolescents - who otherwise disapprove of illegal drug use - is independently associated with a 33% increased risk of opioid misuse in later life. Furthermore, persistent opioid use may be the most common complication after elective surgery. Currently, in our department, much like many other oral and maxillofacial surgical centers, there is a "standardized" prescription of opioids, such as hydromorphone, for all participants being discharged from the hospital. However, it is clear from the literature and anecdotal evidence that most participants do not require as much opioids as we currently prescribe.
In the last few years, there have been recent initiatives to personalize post-operative pain management in orthopedic joint replacement as well as spine surgeries. In these studies, the primary consideration for opioid dosing and frequency following discharge relies on the participants' opioid requirements while in the hospital. A tapering protocol and cessation timeline following discharge is tailored for each participant based on their in-patient opioid requirements to promote opioid prescription stewardship further. These studies demonstrated a reduction in post-operative opioid consumption, with no changes in perceived pain and participants' satisfaction.
This study aims to assess the postoperative analgesic efficacy, opioid requirement, and total analgesic requirements for participants undergoing orthognathic surgery with a personalized discharge opioid prescription and tapering protocol. The study will compare two groups of participants: one group will receive the standardized prescription plan of hydromorphone, while the other group will receive a personalized prescription plan. The control will receive a standardized discharge prescription of 2-4 milligrams of liquid hydromorphone taken orally every 4 hours as needed for pain, with a total prescription of 40 milligrams of hydromorphone. The experimental group will receive a personalized hydromorphone prescription and tapering protocol for the study group. This prescription will be inferred from the participant's last 24-hour in-patient requirement of opioids before being discharged. The personalized schedule is based on a modification of a prescription schedule for spine and orthopedic joint procedures derived by Dr. Edward Mariano's group at Stanford University's Department of Anesthesiology, Perioperative and Pain Medicine.
Data will be obtained from the pre-admission appointment, and in-patient records including the nursing medication administration record (MAR), intra-operative anaesthesia records, participants' questionnaires, and the first follow-up appointment at 2 weeks. Data collected will include the participant's age, weight, body mass index, sex, pertinent medical and psychiatric history, pre-surgical anxiety, type of orthognathic surgery, length of surgery, length of stay in the hospital, amount and frequency of analgesics taken by the participants while in-hospital, analgesic dosages prescribed to the participants on discharge, amount and frequency of analgesics taken by the participants for each day following discharge, remaining prescribed opioids at the 2-week follow-up appointment, and the participant's self-reported satisfaction and pain on the Defense and Veterans Pain Rating Scale (DVPRS) questionnaire. All patient questionnaires will be recorded via REDCap, a secure online data management software.
Subjects will be stratified into single jaw surgery (i.e. LeFort only, BSSO only, +/- FG), or double jaw (i.e. LeFort and BSSO +/- FG). A Mann-Whitney U Test will be utilized for statistical analysis, with significance assumed at p < 0.05. This study is important as it will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery and also help promote opioid stewardship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of 2 parallel study arms and followed longitudinally. Their allocation to the study arms will be performed by using a random number generator, whereby if the number 0 arises, they are allocated to the control group, and if the number 1 arises, they are assigned to the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Standardized Prescription Group (SOP) | Active comparator | Drug: Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgeryAll participants assigned to the SOP group will be treated as per the current status quo, in which they are given the standardized analgesic prescriptions following discharge from the hospital consisting of: 1. Acetaminophen 975 mg orally every 6 hours for 7 days 2. Ibuprofen 600 mg orally every 6 hours for 7 days 3. Hydromorphone 2-4 mg orally every 6 hours as needed, with a total dispense amount of 40mg. The participants are not given instructions on how to taper their hydromorphone medication, which is the current status quo in our department. |
| Personalized Prescription Group (POP) | Experimental | Drug: Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgeryAll participants assigned to the POP group will receive pre-operative education on the medications that they will be given while they are inpatients and upon discharge, along with a pain medication card to aid their understanding. Medications upon discharge will be: 1. Acetaminophen 975mg orally every 6 hours for 1 week 2. Ibuprofen 600 mg orally every 6 hours for 1 week 3. Hydromorphone - Prescribed with a personalized schedule and tapering protocol based on the participant's last 24-hour in-patient use of opioids. Participants in this arm will also receive tapering instructions as well as an education card to assist them with their tapering protocol upon discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing orthognathic surgery for the correction of dentofacial deformities. Included in the study will be patients who receive single-jaw surgery (i.e. BSSO [Bilateral Sagittal Split Osteotomy, a surgery of the lower jaw] only, or Lefort [osteotomy of the upper jaw] only), or those in the double-jaw surgery category (BSSO and Lefort).
- Patients undergoing a functional genioplasty who have an additional osteotomy included in their surgical plan (i.e. BSSO and/or Lefort).
- Patients undergoing cleft orthognathic surgery.
Key exclusion criteria (10 listed)
- Patients who are under the age of 18 at the time of surgery
- Patients who are contraindicated to undergo elective surgery, including pregnant patients.
- Patients with a history of opioid use disorder.
- Patients on chronic opioids within the past month.
- Patients who have a contraindication for multimodal analgesia (e.g. renal injury precluding the prescription of NSAIDs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgeryPOP participants will be given a personalized opioid prescription with a tapering protocol based on their last inpatient 24-hour usage of opioids, obtained from the nursing medication administration record. Should a participant stay in the hospital for less than 24 hours (e.g. patient had an early discharge at 18 hours), the 24-hour in-patient opioid usage would be extrapolated from their total amount and frequency of opioid use. The participant will be provided with an instruction card with suggestions on how much opioid to take at various time points following discharge to safely taper their medication. | Drug | Personalized Prescription Group (POP) |
| Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgerySOP participants will be given a standardized dose of hydromorphone (2-4mg orally every 6 hours), and a total amount of 40mg. No further information is provided to them with regards to their pain medication and to tapering. | Drug | Standardized Prescription Group (SOP) |
Primary outcome
Fraction (%) of remaining unused opioid
Time frame: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement. The remaining opioid is compared to their prescribed opioid to determine the relative amount of unused opioid measured as a percentage.
Absolute amount (milligrams) of remaining unused opioid
Time frame: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement. The remaining opioid is compared to their prescribed opioid to determine the absolute amount of unused opioid measured in milligrams.
4 secondary outcomes
Overall satisfaction with post-surgical pain management at home
Time frame: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication.
Mean duration of usage of opioids
Time frame: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Total daily use of opioid by the participant
Time frame: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Average daily pain scores following discharge
Time frame: Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 35526579Bousquet B, Green MA, Caillouette CN, Simon J, Padwa BL, Resnick CM. How Much Opioid Medication Do Patients Need After Orthognathic Surgery? J Oral Maxillofac Surg. 2022 Jul;80(7):1174-1182. doi: 10.1016/j.joms.2022.04.002. Epub 2022 Apr 7.
- Background: PubMed 34878527Macintyre PE, Quinlan J, Levy N, Lobo DN. Current Issues in the Use of Opioids for the Management of Postoperative Pain: A Review. JAMA Surg. 2022 Feb 1;157(2):158-166. doi: 10.1001/jamasurg.2021.6210.
- Background: PubMed 26516461Pathan H, Williams J. Basic opioid pharmacology: an update. Br J Pain. 2012 Feb;6(1):11-6. doi: 10.1177/2049463712438493.
- Background: PubMed 11207668Borgland SL. Acute opioid receptor desensitization and tolerance: is there a link? Clin Exp Pharmacol Physiol. 2001 Mar;28(3):147-54. doi: 10.1046/j.1440-1681.2001.03418.x.
- Background: PubMed 28226333Kaye AD, Jones MR, Kaye AM, Ripoll JG, Galan V, Beakley BD, Calixto F, Bolden JL, Urman RD, Manchikanti L. Prescription Opioid Abuse in Chronic Pain: An Updated Review of Opioid Abuse Predictors and Strategies to Curb Opioid Abuse: Part 1. Pain Physician. 2017 Feb;20(2S):S93-S109.
- Background: PubMed 29911818Belzak L, Halverson J. The opioid crisis in Canada: a national perspective. Health Promot Chronic Dis Prev Can. 2018 Jun;38(6):224-233. doi: 10.24095/hpcdp.38.6.02.
- Background: PubMed 26504126Miech R, Johnston L, O'Malley PM, Keyes KM, Heard K. Prescription Opioids in Adolescence and Future Opioid Misuse. Pediatrics. 2015 Nov;136(5):e1169-77. doi: 10.1542/peds.2015-1364.
- Background: PubMed 32584407Lawal OD, Gold J, Murthy A, Ruchi R, Bavry E, Hume AL, Lewkowitz AK, Brothers T, Wen X. Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e207367. doi: 10.1001/jamanetworkopen.2020.7367.
- Background: PubMed 24519537Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
- Background: PubMed 31710680Tamboli M, Mariano ER, Gustafson KE, Briones BL, Hunter OO, Wang RR, Harrison TK, Kou A, Mudumbai SC, Kim TE, Indelli PF, Giori NJ. A Multidisciplinary Patient-Specific Opioid Prescribing and Tapering Protocol Is Associated with a Decrease in Total Opioid Dose Prescribed for Six Weeks After Total Hip Arthroplasty. Pain Med. 2020 Nov 7;21(7):1474-1481. doi: 10.1093/pm/pnz260.
- Background: PubMed 32238478Joo SS, Hunter OO, Tamboli M, Leng JC, Harrison TK, Kassab K, Keeton JD, Skirboll S, Tharin S, Saleh E, Mudumbai SC, Wang RR, Kou A, Mariano ER. Implementation of a patient-specific tapering protocol at discharge decreases total opioid dose prescribed for 6 weeks after elective primary spine surgery. Reg Anesth Pain Med. 2020 Jun;45(6):474-478. doi: 10.1136/rapm-2020-101324. Epub 2020 Mar 31.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Individual participant dataSharing planned: No. There is no plan to make the individual participant data (IPD) collected in this study available to other researchers. This decision was made to protect the privacy of the participants involved in the study and to ensure that their personal information is not shared without their consent. All data collected to be shared outside of the research team will be aggregated data for the purpose of publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Alsabbagh, DDS principal investigator
Dalhousie University
Jean-Charles Doucet, DMD, MD, MSc study chair
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery and Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery in people with Pain, Postoperative and Orthognathic Surgery, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction (%) of remaining unused opioid (time frame: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708521, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.