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

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04725357

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Drug: Meloxicam 15 mg Procedure: Preoperative Interscalene Nerve Block Procedure: arthroscopic labral repair	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 25, 2021

Anticipated Primary Completion Date :

Jan 25, 2022

Anticipated Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arthroscopic Labral Repair + postoperative Meloxicam After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam	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 Procedure: arthroscopic labral repair participant will have their standard surgical procedure done
Active Comparator: Arthroscopic Labral Repair without Meloxicam After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)	Procedure: Preoperative Interscalene Nerve Block Preoperatively participants will standardly receive an interscalene nerve block Procedure: arthroscopic labral repair participant will have their standard surgical procedure done

Arm

Intervention/Treatment

Experimental: Arthroscopic Labral Repair + postoperative Meloxicam

After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam

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

Procedure: arthroscopic labral repair

participant will have their standard surgical procedure done

Active Comparator: Arthroscopic Labral Repair without Meloxicam

After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)

Procedure: Preoperative Interscalene Nerve Block

Preoperatively participants will standardly receive an interscalene nerve block

Procedure: arthroscopic labral repair

participant will have their standard surgical procedure done

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT04725357

Other Study ID Numbers:

JHOR20D.1216

First Posted:

Jan 26, 2021

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Shoulder Pain

Meloxicam

Study Results

No Results Posted as of Jan 26, 2021