Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Drug: Normal Saline; Drug: 0.5% bupivacaine

• Registration Number: NCT01126593
• Lead Sponsor: Orlando Health, Inc.

Brief Summary

Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.

Detailed Description

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Results First Submitted: 2013-11-06
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-06
• Last Update Submitted: 2014-11-06
• Results First Posted: 2014-11-07
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Full thickness rotator cuff tear
• Pre operative MRI
• Patients who are medically stable to undergo the surgery
• Patients who consent to involvement in the study

Exclusion Criteria

• Prior surgery on the involved shoulder
• Preoperative MRI suggesting that the rotator cuff tear is unrepairable
• Patients with known allergies to oxycodone, bupivacaine or a similar drug
• Workman's compensation patients
• Patients who do not fill out their visual analog scores or their medication diaries.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Normal Saline	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.
Study Group	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 infusion rate will be 4cc per hour.

Primary Outcome Measures

Name	Time	Method
Pain Scores	O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.	Pain was measured via Visual Analong Scale in measurement (0-100mm).

Trial Locations

Locations (1)

Orlando Orthopaedic Center; 🇺🇸 Orlando, Florida, United States