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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725357
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 25, 2021
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : January 25, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

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




Primary Outcome Measures :
  1. Total Analgesic use [ Time Frame: 14 days ]
    Participants will be given a survey asking about number of pills taken

  2. Postoperative Pain Control [ Time Frame: 14 days ]
    Measured by the Numerical Rating Scale (NRS) pain score daily after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725357


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04725357    
Other Study ID Numbers: JHOR20D.1216
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action