Back to resultsDoes Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
Primary Purpose
Shoulder Pain
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Meloxicam 15 mg
Preoperative Interscalene Nerve Block
arthroscopic labral repair
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- Scheduled for arthroscopic labrum repair of the shoulder
Exclusion Criteria:
- History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
- Currently on long-term preoperative narcotics
- Scheduled for revision arthroscopic repairs of the shoulder
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative surveys
- History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)
- Patients under the age of 18
- Pregnant or breastfeeding women
- Scheduled for concurrent procedures
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arthroscopic Labral Repair + postoperative Meloxicam
Arthroscopic Labral Repair without Meloxicam
Arm Description
After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)
Outcomes
Primary Outcome Measures
Total Analgesic use
Participants will be given a survey asking about number of pills taken
Postoperative Pain Control
Measured by the Numerical Rating Scale (NRS) pain score daily after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04725357
First Posted
January 18, 2021
Last Updated
January 22, 2021
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04725357
Brief Title
Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
Official Title
A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Anticipated)
Primary Completion Date
January 25, 2022 (Anticipated)
Study Completion Date
January 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Labral Repair + postoperative Meloxicam
Arm Type
Experimental
Arm Description
After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
Arm Title
Arthroscopic Labral Repair without Meloxicam
Arm Type
Active Comparator
Arm Description
After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)
Intervention Type
Drug
Intervention Name(s)
Meloxicam 15 mg
Intervention Description
Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery
Intervention Type
Procedure
Intervention Name(s)
Preoperative Interscalene Nerve Block
Intervention Description
Preoperatively participants will standardly receive an interscalene nerve block
Intervention Type
Procedure
Intervention Name(s)
arthroscopic labral repair
Intervention Description
participant will have their standard surgical procedure done
Primary Outcome Measure Information:
Title
Total Analgesic use
Description
Participants will be given a survey asking about number of pills taken
Time Frame
14 days
Title
Postoperative Pain Control
Description
Measured by the Numerical Rating Scale (NRS) pain score daily after surgery
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18
Scheduled for arthroscopic labrum repair of the shoulder
Exclusion Criteria:
History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
Currently on long-term preoperative narcotics
Scheduled for revision arthroscopic repairs of the shoulder
Unable/unwilling to consent for enrollment
Unable to complete postoperative surveys
History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)
Patients under the age of 18
Pregnant or breastfeeding women
Scheduled for concurrent procedures
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
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