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Trial record 58 of 543 for:    Celecoxib

Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03305068
Recruitment Status : Active, not recruiting
First Posted : October 9, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
St. Louis Joint Replacement Institute

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.


Condition or disease Intervention/treatment Phase
Reverse or Primary Total Shoulder Rotator Cuff- Full Thickness- Repair Drug: Celecoxib Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery: A Randomized Controlled Study
Study Start Date : February 2014
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Placebo Comparator: the use of a COX-II inhibitor in shoulder surgery.
Arm 1 shoulder replacement, both primary and reverse
Drug: Celecoxib
Placebo Comparator: the use of a COX-II inhibitor in arhroscopic shoulder surgery.
Arm 2 arthroscopic rotator cuff repair
Drug: Celecoxib



Primary Outcome Measures :
  1. This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption. [ Time Frame: 3 weeks ]
  2. This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion / Exclusion Criteria for Pfizer Study

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

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): NCT03305068


Locations
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United States, Missouri
SSM DePaul
Bridgeton, Missouri, United States, 63044
Sponsors and Collaborators
St. Louis Joint Replacement Institute
Investigators
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Principal Investigator: Katherine Burns, MD SSM orthopedics

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Responsible Party: St. Louis Joint Replacement Institute
ClinicalTrials.gov Identifier: NCT03305068     History of Changes
Other Study ID Numbers: BI177194
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Celecoxib
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