Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

• ClinicalTrials.gov Identifier: NCT01126593
• Recruitment Status: Completed
• First Posted: May 19, 2010
• Results First Posted: November 7, 2014
• Last Update Posted: November 7, 2014
• Sponsor: Orlando Health, Inc.
• Information provided by (Responsible Party): Paula J. Harriott, Orlando Health, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear	Drug: 0.5% bupivacaine; Drug: Normal Saline	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.
• Study Start Date: December 2008
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: February 2010

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Florida

Orlando Orthopaedic Center

Orlando, Florida, United States, 32806

Sponsors and Collaborators

Orlando Health, Inc.

Investigators

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

More Information

• Responsible Party: Paula J. Harriott, Orthopedic surgeon, Orlando Orthopaedic Center, Orlando Health, Inc.
• ClinicalTrials.gov Identifier: NCT01126593
• Other Study ID Numbers: 708009
• First Posted: May 19, 2010
• Results First Posted: November 7, 2014
• Last Update Posted: November 7, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents