Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?

Phase 3

• Conditions: Shoulder Pain
• Interventions: Drug: Meloxicam 15 mg; Procedure: Preoperative Interscalene Nerve Block; Procedure: arthroscopic labral repair

• Registration Number: NCT04725357
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-22
• Last Update Submitted: 2021-01-22
• Study Start: 2021-01-25
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26
• Primary Completion: 2022-01-25
• Study Completion: 2022-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic Labral Repair + postoperative Meloxicam	Meloxicam 15 mg	After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
Arthroscopic Labral Repair without Meloxicam	Preoperative Interscalene Nerve Block	After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)
Arthroscopic Labral Repair + postoperative Meloxicam	Preoperative Interscalene Nerve Block	After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
Arthroscopic Labral Repair + postoperative Meloxicam	arthroscopic labral repair	After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
Arthroscopic Labral Repair without Meloxicam	arthroscopic labral repair	After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)

Primary Outcome Measures

Name	Time	Method
Total Analgesic use	14 days	Participants will be given a survey asking about number of pills taken
Postoperative Pain Control	14 days	Measured by the Numerical Rating Scale (NRS) pain score daily after surgery

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States