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NCT04725357 Clinical Trial

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

Shoulder Pain Clinical Trial

Official title:
A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04725357
Other study ID # JHOR20D.1216
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date January 25, 2021
Est. completion date January 25, 2022

Study information
Verified date January 2021
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 96
Est. completion date January 25, 2022
Est. primary completion date January 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Meloxicam 15 mg
Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery
Procedure:
• Preoperative Interscalene Nerve Block
Preoperatively participants will standardly receive an interscalene nerve block
• arthroscopic labral repair
participant will have their standard surgical procedure done

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Analgesic use Participants will be given a survey asking about number of pills taken 14 days
Primary Postoperative Pain Control Measured by the Numerical Rating Scale (NRS) pain score daily after surgery 14 days
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