Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05974423 |
Recruitment Status :
Enrolling by invitation
First Posted : August 3, 2023
Last Update Posted : August 3, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain, Acute Opioid Use Labral Tear, Glenoid | Drug: Tylenol, Ibuprofen, and Oxycodone Drug: Tylenol and Ibuprofen only | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be assigned to one of the following groups:
|
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair |
Actual Study Start Date : | December 16, 2022 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Control - Narcotic Prescription
|
Drug: Tylenol, Ibuprofen, and Oxycodone
A script for these three medications will be provided
Other Name: Both Narcotic and Non-narcotic |
Experimental: Experimental - Non-narcotic only
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:
|
Drug: Tylenol and Ibuprofen 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
Other Name: Non-narcotic only |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients between the ages of 15 - 25 years old
- Patients with a diagnosis of a labrum tear who will undergo surgical intervention
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05974423
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 |
Principal Investigator: | Catherine J Fedorka, MD | Cooper Hospital Orthopedic Surgery |
Responsible Party: | The Cooper Health System |
ClinicalTrials.gov Identifier: | NCT05974423 |
Other Study ID Numbers: |
IRB 22-193 |
First Posted: | August 3, 2023 Key Record Dates |
Last Update Posted: | August 3, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Labrum repair opioid consumption postoperative pain |
Pain, Postoperative Rotator Cuff Injuries Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries Acetaminophen Ibuprofen Oxycodone Narcotics |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Central Nervous System Depressants Antipyretics |