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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

Tracking Information
First Submitted Date  ICMJE January 18, 2021
First Posted Date  ICMJE January 26, 2021
Last Update Posted Date January 26, 2021
Estimated Study Start Date  ICMJE January 25, 2021
Estimated Primary Completion Date January 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2021)
  • Total Analgesic use [ Time Frame: 14 days ]
    Participants will be given a survey asking about number of pills taken
  • Postoperative Pain Control [ Time Frame: 14 days ]
    Measured by the Numerical Rating Scale (NRS) pain score daily after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
Official Title  ICMJE A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Shoulder Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arthroscopic Labral Repair + postoperative Meloxicam
    After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam
    Interventions:
    • Drug: Meloxicam 15 mg
    • Procedure: Preoperative Interscalene Nerve Block
    • Procedure: arthroscopic labral repair
  • Active Comparator: Arthroscopic Labral Repair without Meloxicam
    After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)
    Interventions:
    • Procedure: Preoperative Interscalene Nerve Block
    • Procedure: arthroscopic labral repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 22, 2021)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 25, 2022
Estimated Primary Completion Date January 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04725357
Other Study ID Numbers  ICMJE JHOR20D.1216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP