Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Drug: Normal Saline; Drug: 0.5% bupivacaine

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Marcaine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Investigators: Principal Investigator: Randy Schwartzberg, MD, Orlando Orthopaedic Center and Orlando Health, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 18, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 19, 2010

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 708009