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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status and phase

Unknown
Phase 3

Conditions

Shoulder Pain

Treatments

Drug: Meloxicam 15 mg
Procedure: arthroscopic labral repair
Procedure: Preoperative Interscalene Nerve Block

Study type

Interventional

Funder types

Other

Identifiers

NCT04725357
JHOR20D.1216

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Arthroscopic Labral Repair + postoperative Meloxicam
Experimental group
Description:
After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
Treatment:
Drug: Meloxicam 15 mg
Procedure: arthroscopic labral repair
Procedure: Preoperative Interscalene Nerve Block
Arthroscopic Labral Repair without Meloxicam
Active Comparator group
Description:
After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)
Treatment:
Procedure: arthroscopic labral repair
Procedure: Preoperative Interscalene Nerve Block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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