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Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery

NCT03305068 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-04-27

No results posted yet for this study

Summary

Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively.

Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.

Conditions

  • Reverse or Primary Total Shoulder
  • Rotator Cuff- Full Thickness- Repair

Interventions

DRUG

Celecoxib

Sponsors & Collaborators

  • St. Louis Joint Replacement Institute

    lead OTHER

Principal Investigators

  • Katherine Burns, MD · SSM orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-03-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305068 on ClinicalTrials.gov