Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.|
- Pain Scores [ Time Frame: O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours. ] [ Designated as safety issue: Yes ]Pain was measured via Visual Analong Scale in measurement (0-100mm).
|Study Start Date:||December 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo group
The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
Drug: Normal Saline
The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.
Other Name: Saline
No Intervention: Control group
The control group patients will receive no continuous infusion catheter.
Experimental: Study Group
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
Drug: 0.5% bupivacaine
Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.
Other Name: Marcaine
This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.
Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126593
|United States, Florida|
|Orlando Orthopaedic Center|
|Orlando, Florida, United States, 32806|
|Principal Investigator:||Randy Schwartzberg, MD||Orlando Orthopaedic Center and Orlando Health, Inc.|