NCT04725357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 18, 2021

Last Update Submit

January 22, 2021

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (2)

  • Total Analgesic use

    Participants will be given a survey asking about number of pills taken

    14 days

  • Postoperative Pain Control

    Measured by the Numerical Rating Scale (NRS) pain score daily after surgery

    14 days

Study Arms (2)

Arthroscopic Labral Repair + postoperative Meloxicam

EXPERIMENTAL

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

Drug: Meloxicam 15 mgProcedure: Preoperative Interscalene Nerve BlockProcedure: arthroscopic labral repair

Arthroscopic Labral Repair without Meloxicam

ACTIVE COMPARATOR

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

Procedure: Preoperative Interscalene Nerve BlockProcedure: arthroscopic labral repair

Interventions

Meloxicam 15 mgDRUG

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

Arthroscopic Labral Repair + postoperative Meloxicam
Preoperative Interscalene Nerve BlockPROCEDURE

Preoperatively participants will standardly receive an interscalene nerve block

Arthroscopic Labral Repair + postoperative MeloxicamArthroscopic Labral Repair without Meloxicam
arthroscopic labral repairPROCEDURE

participant will have their standard surgical procedure done

Arthroscopic Labral Repair + postoperative MeloxicamArthroscopic Labral Repair without Meloxicam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Scheduled for arthroscopic labrum repair of the shoulder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 26, 2021

Study Start

January 25, 2021

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

US(1)