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

NCT ID: NCT04725357

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arthroscopic Labral Repair + postoperative Meloxicam

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

Group Type EXPERIMENTAL

Meloxicam 15 mg

Intervention Type DRUG

Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery

Preoperative Interscalene Nerve Block

Intervention Type PROCEDURE

Preoperatively participants will standardly receive an interscalene nerve block

arthroscopic labral repair

Intervention Type PROCEDURE

participant will have their standard surgical procedure done

Arthroscopic Labral Repair without Meloxicam

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

Group Type ACTIVE_COMPARATOR

Preoperative Interscalene Nerve Block

Intervention Type PROCEDURE

Preoperatively participants will standardly receive an interscalene nerve block

arthroscopic labral repair

Intervention Type PROCEDURE

participant will have their standard surgical procedure done

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meloxicam 15 mg

Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery

Intervention Type DRUG

Preoperative Interscalene Nerve Block

Preoperatively participants will standardly receive an interscalene nerve block

Intervention Type PROCEDURE

arthroscopic labral repair

participant will have their standard surgical procedure done

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JHOR20D.1216

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Opioid-Free Shoulder Arthroplasty
NCT03540030 COMPLETED PHASE4
Meloxicam in Mohs Micrographic Surgery
NCT07200544 RECRUITING PHASE4
Exparel for Total Shoulder Pain
NCT03739021 NOT_YET_RECRUITING PHASE2/PHASE3
CBD for Pain Following Orthopedic Shoulder Surgery
NCT06381791 RECRUITING PHASE1/PHASE2
Opioid-Sparing Joint Replacement
NCT07348627 NOT_YET_RECRUITING PHASE3
ESPB vs iPACK+ACB in Total Knee Arthroplasty
NCT06302218 NOT_YET_RECRUITING PHASE4
Pain Control After Lumbar Spine Fusion
NCT06484192 ENROLLING_BY_INVITATION PHASE4