Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery

NCT ID: NCT03305068

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-06-30

Brief 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.

Detailed Description

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

the use of a COX-II inhibitor in shoulder surgery.

Arm 1 shoulder replacement, both primary and reverse

Group Type: PLACEBO_COMPARATOR

Celecoxib

Intervention Type: DRUG

the use of a COX-II inhibitor in arhroscopic shoulder surgery.

Arm 2 arthroscopic rotator cuff repair

Group Type: PLACEBO_COMPARATOR

Celecoxib

Intervention Type: DRUG

Interventions

Celecoxib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. community ambulators

2. D/C to home only

3. only MO and IL pts

4. Primary unilateral shoulder replacements / Cuff tear

5. Full Thickness, single tendon tear

Exclusion Criteria

1. allergy, sensitivity, or inability to take Celebrex

2. CR >1.5

3. h/o bleeding ulcers

4. h/o Inflammatory bowel disease, Crohn's disease, ulcerative colitis

5. Coagulation abnormality

6. Coumadin/Plavix/Xaralto

7. CHF

8. Previous MI or CVA

9. Current use of long acting narcotics (Fentanyl Patches, Oxycontin CR, MS Contin)

10. Refusal by PCP or cardiologist

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis Joint Replacement Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Burns, MD

Role: PRINCIPAL_INVESTIGATOR

SSM orthopedics

Locations

SSM DePaul

Bridgeton, Missouri, United States

Countries

United States

Other Identifiers

BI177194

Identifier Type: -

Identifier Source: org_study_id