Bunion of Unspecified FootNCT04771741
Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
An observational study of Bunion of Unspecified Foot and Bunionette of Unspecified Foot, run by Prisma Health-Midlands at 1 site in United States.
Trial summary
Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe
- What is being tested?
- Acetominophen, Toradol and Meloxicam
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included in this study will be adult outpatient, elective, primary foot and ankle surgery that is not due to infection performed at Prisma Health Orthopedics.
Who may be able to join
- ≥18 years of age
- Outpatient, elective, primary foot and ankle surgery not due to infection including:
- Bunion or bunionette surgery, hammertoe surgery, ankle fracture, Achilles tendon surgery (primary mid-substance repair, Haglund's deformity correction with debridement), ankle arthroscopy
Who cannot join
- <18 years of age
- Undergoing revision surgery
- Allergic to more than 1 medication listed in protocol
- Creatinine clearance >1.5
- Known end-stage renal, stage 2 or higher
- History of GI bleed, ulcer, NSAID-induced gastritis, and/or gastric bypass
Show all 10Show fewer
- History of active liver disease or Child-Pugh Class 2 liver failure or above
- History of pain syndromes including: fibromyalgia, complex regional pain syndrome/reflex sympathetic dystrophy, hyperalgesia
- Inability to undergo regional anesthesia due to inability to obtain nerve block, prior nerve damage or anatomy, or anesthesiologic best judgement
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Midlands
Columbia, South Carolina, 29203
About this study
Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.
Read the detailed description
Despite the presence and increased understanding of the opioid crisis in the United States, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period. In an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. There have been early studies reporting the results of non-narcotic protocols during the intra-operative period. Likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. However, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. Currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.
- Conditions
- Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe, Ankle Fractures, Achilles Tendon Surgery
- Being tested
- Acetominophen, Toradol, Meloxicam, Cyclobenzaprine, Lyrica
- Medical subject headings
- Hammer Toe Syndrome, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetominophenDrug
Also called Tylenol
1,000 mg every 6 hours
ToradolDrug
Also called Ketorolac
10 mg every 6 hours, days 0-3
MeloxicamDrug
Also called Mobic
15 mg once daily, beginning post-op day 4
CyclobenzaprineDrug
Also called Flexeril
10 mg every 8 hours
LyricaDrug
Also called Pregabalin
75 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Pain Pathway | This group will receive the multimodal pain pathway cocktail of medications. This cocktail includes:
* Tylenol (acetominophen), 1000 mg, every 6 hours as needed for pain
* Ketorolac (Toradol), 10 mg, every 6 hours as needed for pain until post-op day 3
* Mobic (Meloxicam), 15 mg once daily, beginning on post-op day 4
* Flexeril (Cyclobenzaprine), 10 mg every 8 hours as needed for pain
* Pregabalin (Lyrica), 75 mg every 12 hours as needed for pain Receives: Drug: Acetominophen; Drug: Toradol; Drug: Meloxicam; Drug: Cyclobenzaprine; Drug: Lyrica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with opioid-free multimodal postoperative protocol.
Study participants will complete a survey at the 2 week follow-up visit asking yes or no if they were satisfied with the opioid-free pain management protocol.
Measured: 2 weeks
Rate of failure of opioid-free multimodal postoperative protocol.
At 2 weeks, patients will be asked yes or no if they used any additional medications for pain outside of prescriptions that were provided in the opioid-free multimodal pain protocol.
Measured: 2 weeks
Secondary outcomes (3)
Post-operative Pain: Day 1
Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 1.
Measured: 1 day
Post-operative Pain: Day 3
Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 3.
Measured: 3 days
Post-operative Pain: Day 8
Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 8.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bunion of Unspecified FootStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Benjamin Jackson, MD, MBA, Principal investigator, Prisma Health-Midlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771741
- Sponsor's protocol ID
- Pro00099067
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haddad DK, Sherman OH. Developing opioid prescribing recommendations in the postoperative orthopedic setting. J Opioid Manag. 2019 Jul/Aug;15(4):333-341. doi: 10.5055/jom.2019.0518.
PubMed 31637685Janakiram C, Fontelo P, Huser V, Chalmers NI, Lopez Mitnik G, Brow AR, Iafolla TJ, Dye BA. Opioid Prescriptions for Acute and Chronic Pain Management Among Medicaid Beneficiaries. Am J Prev Med. 2019 Sep;57(3):365-373. doi: 10.1016/j.amepre.2019.04.022. Epub 2019 Aug 1.
PubMed 31377093Young JD, Bhashyam AR, Qudsi RA, Parisien RL, Shrestha S, van der Vliet QMJ, Fils J, Losina E, Dyer GSM. Cross-Cultural Comparison of Postoperative Discharge Opioid Prescribing After Orthopaedic Trauma Surgery. J Bone Joint Surg Am. 2019 Jul 17;101(14):1286-1293. doi: 10.2106/JBJS.18.01022.
PubMed 31318808Bean BA, Connor PM, Schiffern SC, Hamid N. Outpatient Shoulder Arthroplasty at an Ambulatory Surgery Center Using a Multimodal Pain Management Approach. J Am Acad Orthop Surg Glob Res Rev. 2018 Oct 23;2(10):e064. doi: 10.5435/JAAOSGlobal-D-18-00064. eCollection 2018 Oct.
PubMed 30656252Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.
PubMed 30214945Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study. J Spinal Disord Tech. 2013 Aug;26(6):291-7. doi: 10.1097/BSD.0b013e318246b0a6.
PubMed 23887076Seiter M, Aiyer A. Current Trends in Anesthesia Management in Hallux Valgus. Foot Ankle Clin. 2020 Mar;25(1):47-57. doi: 10.1016/j.fcl.2019.10.002. Epub 2019 Nov 20.
PubMed 31997746Lee JK, Kang C, Hwang DS, Lee GS, Hwang JM, Park EJ, Ga IH. An Innovative Pain Control Method Using Peripheral Nerve Block and Patient-Controlled Analgesia With Ketorolac After Bone Surgery in the Ankle Area: A Prospective Study. J Foot Ankle Surg. 2020 Jul-Aug;59(4):698-703. doi: 10.1053/j.jfas.2019.12.001. Epub 2020 Feb 10.
PubMed 32057624Michelson JD, Addante RA, Charlson MD. Multimodal analgesia therapy reduces length of hospitalization in patients undergoing fusions of the ankle and hindfoot. Foot Ankle Int. 2013 Nov;34(11):1526-34. doi: 10.1177/1071100713496224. Epub 2013 Jul 8.
PubMed 23836812McDonald EL, Daniel JN, Rogero RG, Shakked RJ, Nicholson K, Pedowitz DI, Raikin SM, Bilolikar V, Winters BS. How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery? Clin Orthop Relat Res. 2020 Jan;478(1):144-151. doi: 10.1097/CORR.0000000000000978.
PubMed 31567579
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT04771741
- Acronym / sponsor ID
- Pro00099067
- Conditions
- Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe, Ankle Fractures, Achilles Tendon Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 25 Feb 2021 (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.
Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.
Detailed description
Despite the presence and increased understanding of the opioid crisis in the United States, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period. In an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. There have been early studies reporting the results of non-narcotic protocols during the intra-operative period. Likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. However, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. Currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Pain Pathway | – | Drug: Acetominophen, Drug: Toradol, Drug: Meloxicam, Drug: Cyclobenzaprine, Drug: LyricaThis group will receive the multimodal pain pathway cocktail of medications. This cocktail includes: * Tylenol (acetominophen), 1000 mg, every 6 hours as needed for pain * Ketorolac (Toradol), 10 mg, every 6 hours as needed for pain until post-op day 3 * Mobic (Meloxicam), 15 mg once daily, beginning on post-op day 4 * Flexeril (Cyclobenzaprine), 10 mg every 8 hours as needed for pain * Pregabalin (Lyrica), 75 mg every 12 hours as needed for pain |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included in this study will be adult outpatient, elective, primary foot and ankle surgery that is not due to infection performed at Prisma Health Orthopedics.
Key inclusion criteria (3 listed)
- ≥18 years of age
- Outpatient, elective, primary foot and ankle surgery not due to infection including:
- Bunion or bunionette surgery, hammertoe surgery, ankle fracture, Achilles tendon surgery (primary mid-substance repair, Haglund's deformity correction with debridement), ankle arthroscopy
Key exclusion criteria (10 listed)
- <18 years of age
- Undergoing revision surgery
- Allergic to more than 1 medication listed in protocol
- Creatinine clearance >1.5
- Known end-stage renal, stage 2 or higher
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 |
|---|---|---|
| AcetominophenAlso: Tylenol1,000 mg every 6 hours | Drug | Multimodal Pain Pathway |
| ToradolAlso: Ketorolac10 mg every 6 hours, days 0-3 | Drug | Multimodal Pain Pathway |
| MeloxicamAlso: Mobic15 mg once daily, beginning post-op day 4 | Drug | Multimodal Pain Pathway |
| CyclobenzaprineAlso: Flexeril10 mg every 8 hours | Drug | Multimodal Pain Pathway |
| LyricaAlso: Pregabalin75 mg every 12 hours | Drug | Multimodal Pain Pathway |
Primary outcome
Patient satisfaction with opioid-free multimodal postoperative protocol.
Time frame: 2 weeks
Study participants will complete a survey at the 2 week follow-up visit asking yes or no if they were satisfied with the opioid-free pain management protocol.
Rate of failure of opioid-free multimodal postoperative protocol.
Time frame: 2 weeks
At 2 weeks, patients will be asked yes or no if they used any additional medications for pain outside of prescriptions that were provided in the opioid-free multimodal pain protocol.
3 secondary outcomes
Post-operative Pain: Day 1
Time frame: 1 day
Post-operative Pain: Day 3
Time frame: 3 days
Post-operative Pain: Day 8
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 31637685Haddad DK, Sherman OH. Developing opioid prescribing recommendations in the postoperative orthopedic setting. J Opioid Manag. 2019 Jul/Aug;15(4):333-341. doi: 10.5055/jom.2019.0518.
- Background: PubMed 31377093Janakiram C, Fontelo P, Huser V, Chalmers NI, Lopez Mitnik G, Brow AR, Iafolla TJ, Dye BA. Opioid Prescriptions for Acute and Chronic Pain Management Among Medicaid Beneficiaries. Am J Prev Med. 2019 Sep;57(3):365-373. doi: 10.1016/j.amepre.2019.04.022. Epub 2019 Aug 1.
- Background: PubMed 31318808Young JD, Bhashyam AR, Qudsi RA, Parisien RL, Shrestha S, van der Vliet QMJ, Fils J, Losina E, Dyer GSM. Cross-Cultural Comparison of Postoperative Discharge Opioid Prescribing After Orthopaedic Trauma Surgery. J Bone Joint Surg Am. 2019 Jul 17;101(14):1286-1293. doi: 10.2106/JBJS.18.01022.
- Background: PubMed 30656252Bean BA, Connor PM, Schiffern SC, Hamid N. Outpatient Shoulder Arthroplasty at an Ambulatory Surgery Center Using a Multimodal Pain Management Approach. J Am Acad Orthop Surg Glob Res Rev. 2018 Oct 23;2(10):e064. doi: 10.5435/JAAOSGlobal-D-18-00064. eCollection 2018 Oct.
- Background: PubMed 30214945Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.
- Background: PubMed 23887076Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study. J Spinal Disord Tech. 2013 Aug;26(6):291-7. doi: 10.1097/BSD.0b013e318246b0a6.
- Background: PubMed 31997746Seiter M, Aiyer A. Current Trends in Anesthesia Management in Hallux Valgus. Foot Ankle Clin. 2020 Mar;25(1):47-57. doi: 10.1016/j.fcl.2019.10.002. Epub 2019 Nov 20.
- Background: PubMed 32057624Lee JK, Kang C, Hwang DS, Lee GS, Hwang JM, Park EJ, Ga IH. An Innovative Pain Control Method Using Peripheral Nerve Block and Patient-Controlled Analgesia With Ketorolac After Bone Surgery in the Ankle Area: A Prospective Study. J Foot Ankle Surg. 2020 Jul-Aug;59(4):698-703. doi: 10.1053/j.jfas.2019.12.001. Epub 2020 Feb 10.
- Background: PubMed 23836812Michelson JD, Addante RA, Charlson MD. Multimodal analgesia therapy reduces length of hospitalization in patients undergoing fusions of the ankle and hindfoot. Foot Ankle Int. 2013 Nov;34(11):1526-34. doi: 10.1177/1071100713496224. Epub 2013 Jul 8.
- Background: PubMed 31567579McDonald EL, Daniel JN, Rogero RG, Shakked RJ, Nicholson K, Pedowitz DI, Raikin SM, Bilolikar V, Winters BS. How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery? Clin Orthop Relat Res. 2020 Jan;478(1):144-151. doi: 10.1097/CORR.0000000000000978.
- Individual participant dataSharing planned: No
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.
J. Benjamin Jackson, MD, MBA principal investigator
Prisma Health-Midlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bunion of Unspecified Foot and Bunionette of Unspecified Foot, run by Prisma Health-Midlands at 1 site in United States.
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: finished, as of the sponsor's last update on 27 Apr 2023. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction with opioid-free multimodal postoperative protocol. (time frame: 2 weeks). 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 NCT04771741, which also lists 10 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 27 Apr 2023.