Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Condition(s) targeted: Rotator Cuff Tear

Intervention: 0.5% bupivacaine (Drug); Normal Saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Orlando Health, Inc.

Official(s) and/or principal investigator(s):
Randy Schwartzberg, MD, Principal Investigator, Affiliation: Orlando Orthopaedic Center and Orlando Health, Inc.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Pain Scores

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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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.

Orlando Orthopaedic Center, Orlando, Florida 32806, United States

Starting date: December 2008
Last updated: November 6, 2014