Postoperative Pain, AcutePhase 4NCT05974423
Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair
A Phase 4 study testing Tylenol, Ibuprofen, and Oxycodone and Tylenol and Ibuprofen only in people with Postoperative Pain, Acute and Opioid Use, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Postoperative Pain, Acute, Opioid Use, Labral Tear, Glenoid
- What is being tested?
- Tylenol, Ibuprofen, and Oxycodone and Tylenol and Ibuprofen only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2022to 1 Dec 2025
- Phase
- Phase 4
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 15 - 25 years old
- Patients with a diagnosis of a labrum tear who will undergo surgical intervention
Who cannot join
- Patients under the age of 14 years old
- Patients age 26 years or older
- Patients with a nonoperative diagnosis of a labrum tear
- Patients who elect not to undergo surgical treatment
- Patients who are on opioid medications preoperatively
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
Official title: Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair
The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.
Read the detailed description
The opioid crisis has illuminated the risks of opioid use for pain management, with renewed interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory medication is an important component of multimodal pain management for patients undergoing orthopedic surgery. Several relevant studies have inquired about the use of opioid consumption in the management of total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in the literature, however, regarding the use of nerve blocks preoperatively in conjunction with nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce pain levels in patients who have undergone surgical management for shoulder labrum or SLAP lesions. Hopefully, the data we can extract will allow future physicians to decrease the number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.
The United States is currently in an opioid crisis. This is a public health issue that not only is limited to the United States but is echoed by countries around the world. All physicians must be accountable for the continuation of the crisis but also must be cognizant of ways to end the issue. In 2011, the United States Food and Drug Administration reported that 50 million Americans were prescribed opioids which is close to a 100 percent increase in the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the leading cause of accidental death in young adults; associated with a higher risk of postoperative death, and increased risk of falls and fractures in the elderly. Many ways have been discussed to reduce the prescription of opioids such as standardized opioid prescription protocols, limits on prescription size, and restrictions on opioid use for preoperative and nonsurgical patients. Another theater of opioid use that can be addressed is that of post-operative pain management. The contribution of the potential results of our research could greatly reduce and mitigate the number of opioids prescribed postoperatively if there is no significant difference between the groups.
This will be a prospective randomized trial. Patients will be randomly placed into either the control or experimental arm of the study. Every patient will receive Exparel as is the standard of care for this procedure.
There will be two groups in this study:
- Group 1:
- Oxycodone 5 mg 1 tablet every 6 hours PRN
- Tylenol 1000 mg every 8 hours
- Ibuprofen 600 mg every 6 hours as needed for pain
- Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription for oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:
- Tylenol 1000 mg every 8 hours
- Ibuprofen 600 mg every 6 hours as needed for pain
At the time of diagnosis and discussion of surgical intervention, patients will be asked if they would like to participate in this research study. Patients will be considered screen fails should they meet any exclusion criteria. They will be informed that depending on which group they are randomly assigned to, they may have different prescriptions. Should the patient be randomly assigned to the control group, they will be given the above medications. Should the patient be randomly assigned to the experimental group, they will be given the above medication scripts.
To note, for shoulder surgeries, Cooper has been using Exparel as a nerve block agent as part of the standard of care.
Day 1 after surgery: both groups will begin completing their pain journal for 14 days. We will allow two methods to complete the pain journal: REDCap or paper format. The REDCap version will be emailed to patients daily so they can complete the questions. The paper format will be available to all subjects regardless of if they complete the REDCap surveys. This will be an extra measure to ensure all days are reported and there are no issues with the REDCap.
At 2 Weeks post-op: Patients' pain levels with be assessed in the immediate post-operative period at their first follow-up visit with their respective attending physician.
The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
Both groups' subject's involvement will last 2 weeks post-operation. After this 2 week visit, patients will have completed their course of the study.
The current standard of practice at Cooper for orthopedic surgeons performing this procedure is oxycodone 5mg PRN, ibuprofen 600mg every 6 hours, and acetaminophen 1000mg every 8 hours.
- Conditions
- Postoperative Pain, Acute, Opioid Use, Labral Tear, Glenoid
- Being tested
- Tylenol, Ibuprofen, and Oxycodone, Tylenol and Ibuprofen only
- Keywords
- Labrum repair, opioid consumption, postoperative pain
- Medical subject headings
- Pain, Postoperative, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tylenol, Ibuprofen, and OxycodoneDrug
Also called Both Narcotic and Non-narcotic
A script for these three medications will be provided
Tylenol and Ibuprofen onlyDrug
Also called Non-narcotic only
A script for only these two medications will be provided initially following surgery. Should the patient need stronger medication for adequate pain control, the on-call physician will provide a script for oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Control - Narcotic Prescription | Active comparator | 1. Oxycodone 5 mg 1 tablet every 6 hours PRN
2. Tylenol 1000 mg every 8 hours
3. Ibuprofen 600 mg every 6 hours as needed for pain Receives: Drug: Tylenol, Ibuprofen, and Oxycodone |
| Experimental - Non-narcotic only | Experimental | This group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:
1. Tylenol 1000 mg every 8 hours
2. Ibuprofen 600 mg every 6 hours as needed for pain Receives: Drug: Tylenol and Ibuprofen only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control
The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start16 Dec 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to one of the following groups: * Group 1: 1. Oxycodone 5 mg 1 tablet every 6 hours PRN 2. Tylenol 1000 mg every 8 hours 3. Ibuprofen 600 mg every 6 hours as needed for pain * Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions: 1. Tylenol 1000 mg every 8 hours 2. Ibuprofen 600 mg every 6 hours as needed for pain
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Sponsor
- Investigators
- Catherine J Fedorka, MD, Principal investigator, Cooper Hospital Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974423
- Sponsor's protocol ID
- IRB 22-193
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Familiari F, Huri G, Simonetta R, McFarland EG. SLAP lesions: current controversies. EFORT Open Rev. 2019 Jan 28;4(1):25-32. doi: 10.1302/2058-5241.4.180033. eCollection 2019 Jan.
PubMed 30800477Hester WA, O'Brien MJ, Heard WMR, Savoie FH. Current Concepts in the Evaluation and Management of Type II Superior Labral Lesions of the Shoulder. Open Orthop J. 2018 Jul 31;12:331-341. doi: 10.2174/1874325001812010331. eCollection 2018.
PubMed 30197715Jain A, Aniq H, Mistry A. SLAP Injury and the Superior Labrum. Semin Musculoskelet Radiol. 2022 Oct;26(5):577-584. doi: 10.1055/s-0042-1758840. Epub 2022 Dec 19.
PubMed 36535593Matsuki K, Sugaya H. Complications after arthroscopic labral repair for shoulder instability. Curr Rev Musculoskelet Med. 2015 Mar;8(1):53-58. doi: 10.1007/s12178-014-9248-5.
PubMed 25532917Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965O'Neill A, Lirk P. Multimodal Analgesia. Anesthesiol Clin. 2022 Sep;40(3):455-468. doi: 10.1016/j.anclin.2022.04.002. Epub 2022 Aug 2.
PubMed 36049874Elmallah RK, Chughtai M, Khlopas A, Newman JM, Stearns KL, Roche M, Kelly MA, Harwin SF, Mont MA. Pain Control in Total Knee Arthroplasty. J Knee Surg. 2018 Jul;31(6):504-513. doi: 10.1055/s-0037-1604152. Epub 2017 Jul 18.
PubMed 28719941Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.
PubMed 31491863Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.
PubMed 27558150Kaye AD, Novitch MB, Carlson SF, Fuller MC, White SW, Haroldson AR, Kaiser JA, Elkersh MA, Brunk AJ, Jeha GM, Cornett EM. The Role of Exparel Plus Meloxicam for Postoperative Pain Management. Curr Pain Headache Rep. 2020 Jan 30;24(3):6. doi: 10.1007/s11916-020-0837-2.
PubMed 32002676Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9. Epub 2021 Jul 6.
PubMed 34228280
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair
- ClinicalTrials.gov ID
- NCT05974423
- Acronym / sponsor ID
- IRB 22-193
- Conditions
- Postoperative Pain, Acute, Opioid Use, Labral Tear, Glenoid
- Keywords
- Labrum repair, opioid consumption, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Aug 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.
The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.
Detailed description
The opioid crisis has illuminated the risks of opioid use for pain management, with renewed interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory medication is an important component of multimodal pain management for patients undergoing orthopedic surgery. Several relevant studies have inquired about the use of opioid consumption in the management of total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in the literature, however, regarding the use of nerve blocks preoperatively in conjunction with nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce pain levels in patients who have undergone surgical management for shoulder labrum or SLAP lesions. Hopefully, the data we can extract will allow future physicians to decrease the number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.
The United States is currently in an opioid crisis. This is a public health issue that not only is limited to the United States but is echoed by countries around the world. All physicians must be accountable for the continuation of the crisis but also must be cognizant of ways to end the issue. In 2011, the United States Food and Drug Administration reported that 50 million Americans were prescribed opioids which is close to a 100 percent increase in the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the leading cause of accidental death in young adults; associated with a higher risk of postoperative death, and increased risk of falls and fractures in the elderly. Many ways have been discussed to reduce the prescription of opioids such as standardized opioid prescription protocols, limits on prescription size, and restrictions on opioid use for preoperative and nonsurgical patients. Another theater of opioid use that can be addressed is that of post-operative pain management. The contribution of the potential results of our research could greatly reduce and mitigate the number of opioids prescribed postoperatively if there is no significant difference between the groups.
This will be a prospective randomized trial. Patients will be randomly placed into either the control or experimental arm of the study. Every patient will receive Exparel as is the standard of care for this procedure.
There will be two groups in this study:
- Group 1:
- Oxycodone 5 mg 1 tablet every 6 hours PRN
- Tylenol 1000 mg every 8 hours
- Ibuprofen 600 mg every 6 hours as needed for pain
- Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription for oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:
- Tylenol 1000 mg every 8 hours
- Ibuprofen 600 mg every 6 hours as needed for pain
At the time of diagnosis and discussion of surgical intervention, patients will be asked if they would like to participate in this research study. Patients will be considered screen fails should they meet any exclusion criteria. They will be informed that depending on which group they are randomly assigned to, they may have different prescriptions. Should the patient be randomly assigned to the control group, they will be given the above medications. Should the patient be randomly assigned to the experimental group, they will be given the above medication scripts.
To note, for shoulder surgeries, Cooper has been using Exparel as a nerve block agent as part of the standard of care.
Day 1 after surgery: both groups will begin completing their pain journal for 14 days. We will allow two methods to complete the pain journal: REDCap or paper format. The REDCap version will be emailed to patients daily so they can complete the questions. The paper format will be available to all subjects regardless of if they complete the REDCap surveys. This will be an extra measure to ensure all days are reported and there are no issues with the REDCap.
At 2 Weeks post-op: Patients' pain levels with be assessed in the immediate post-operative period at their first follow-up visit with their respective attending physician.
The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
Both groups' subject's involvement will last 2 weeks post-operation. After this 2 week visit, patients will have completed their course of the study.
The current standard of practice at Cooper for orthopedic surgeons performing this procedure is oxycodone 5mg PRN, ibuprofen 600mg every 6 hours, and acetaminophen 1000mg every 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to one of the following groups: * Group 1: 1. Oxycodone 5 mg 1 tablet every 6 hours PRN 2. Tylenol 1000 mg every 8 hours 3. Ibuprofen 600 mg every 6 hours as needed for pain * Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions: 1. Tylenol 1000 mg every 8 hours 2. Ibuprofen 600 mg every 6 hours as needed for pain
| Arm | Type | Receives |
|---|---|---|
| Control - Narcotic Prescription | Active comparator | Drug: Tylenol, Ibuprofen, and Oxycodone1. Oxycodone 5 mg 1 tablet every 6 hours PRN 2. Tylenol 1000 mg every 8 hours 3. Ibuprofen 600 mg every 6 hours as needed for pain |
| Experimental - Non-narcotic only | Experimental | Drug: Tylenol and Ibuprofen onlyThis group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions: 1. Tylenol 1000 mg every 8 hours 2. Ibuprofen 600 mg every 6 hours as needed for pain |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between the ages of 15 - 25 years old
- Patients with a diagnosis of a labrum tear who will undergo surgical intervention
Key exclusion criteria (5 listed)
- Patients under the age of 14 years old
- Patients age 26 years or older
- Patients with a nonoperative diagnosis of a labrum tear
- Patients who elect not to undergo surgical treatment
- Patients who are on opioid medications preoperatively
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 |
|---|---|---|
| Tylenol, Ibuprofen, and OxycodoneAlso: Both Narcotic and Non-narcoticA script for these three medications will be provided | Drug | Control - Narcotic Prescription |
| Tylenol and Ibuprofen onlyAlso: Non-narcotic onlyA script for only these two medications will be provided initially following surgery. Should the patient need stronger medication for adequate pain control, the on-call physician will provide a script for oxycodone | Drug | Experimental - Non-narcotic only |
Primary outcome
Postoperative pain control
Time frame: 2 weeks
The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 30800477Familiari F, Huri G, Simonetta R, McFarland EG. SLAP lesions: current controversies. EFORT Open Rev. 2019 Jan 28;4(1):25-32. doi: 10.1302/2058-5241.4.180033. eCollection 2019 Jan.
- Background: PubMed 30197715Hester WA, O'Brien MJ, Heard WMR, Savoie FH. Current Concepts in the Evaluation and Management of Type II Superior Labral Lesions of the Shoulder. Open Orthop J. 2018 Jul 31;12:331-341. doi: 10.2174/1874325001812010331. eCollection 2018.
- Background: PubMed 36535593Jain A, Aniq H, Mistry A. SLAP Injury and the Superior Labrum. Semin Musculoskelet Radiol. 2022 Oct;26(5):577-584. doi: 10.1055/s-0042-1758840. Epub 2022 Dec 19.
- Background: PubMed 25532917Matsuki K, Sugaya H. Complications after arthroscopic labral repair for shoulder instability. Curr Rev Musculoskelet Med. 2015 Mar;8(1):53-58. doi: 10.1007/s12178-014-9248-5.
- Background: PubMed 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Background: PubMed 36049874O'Neill A, Lirk P. Multimodal Analgesia. Anesthesiol Clin. 2022 Sep;40(3):455-468. doi: 10.1016/j.anclin.2022.04.002. Epub 2022 Aug 2.
- Background: PubMed 28719941Elmallah RK, Chughtai M, Khlopas A, Newman JM, Stearns KL, Roche M, Kelly MA, Harwin SF, Mont MA. Pain Control in Total Knee Arthroplasty. J Knee Surg. 2018 Jul;31(6):504-513. doi: 10.1055/s-0037-1604152. Epub 2017 Jul 18.
- Background: PubMed 31491863Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.
- Background: PubMed 27558150Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.
- Background: PubMed 32002676Kaye AD, Novitch MB, Carlson SF, Fuller MC, White SW, Haroldson AR, Kaiser JA, Elkersh MA, Brunk AJ, Jeha GM, Cornett EM. The Role of Exparel Plus Meloxicam for Postoperative Pain Management. Curr Pain Headache Rep. 2020 Jan 30;24(3):6. doi: 10.1007/s11916-020-0837-2.
- Background: PubMed 34228280Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9. Epub 2021 Jul 6.
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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.
Catherine J Fedorka, MD principal investigator
Cooper Hospital Orthopedic Surgery
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 Tylenol, Ibuprofen, and Oxycodone and Tylenol and Ibuprofen only in people with Postoperative Pain, Acute and Opioid Use, run by Cooper Norcross Health 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 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.
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?
Results are not available in the source record.
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?
Postoperative pain control (time frame: 2 weeks). 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 NCT05974423, which also lists 11 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 3 Aug 2023.