NCT01126593

Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Orlando Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2010-02-01
• First posted: 2010-05-19
• Last updated: 2014-11-07
• Results posted: 2014-11-07

Locations

1 site across 1 country: United States