Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126593
• Other study ID #: 708009
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: November 6, 2014
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2014
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Orlando Orthopaedic Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes