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Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

This study has been completed.
Information provided by (Responsible Party):
Paula J. Harriott, Orlando Health, Inc. Identifier:
First received: May 18, 2010
Last updated: November 6, 2014
Last verified: November 2014
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 Intervention
Rotator Cuff Tear
Drug: 0.5% bupivacaine
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.

Resource links provided by NLM:

Further study details as provided by Orlando Health, Inc.:

Primary Outcome Measures:
  • 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).

Enrollment: 96
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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
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Please refer to this study by its identifier: NCT01126593

United States, Florida
Orlando Orthopaedic Center
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Orlando Health, Inc.
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. Identifier: NCT01126593     History of Changes
Other Study ID Numbers: 708009
Study First Received: May 18, 2010
Results First Received: November 6, 2013
Last Updated: November 6, 2014

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 24, 2017