Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paula J. Harriott, Orlando Health, Inc.
ClinicalTrials.gov Identifier:
NCT01126593
First received: May 18, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Visual Analog scores [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Patients will be instructed preoperativly on filling out the visual analog scores. The patients will be given booklets that will be complete with basic intructions to fill out the form.


Secondary Outcome Measures:
  • Medication log [ Time Frame: One week post op. ] [ Designated as safety issue: No ]
    Patients will fill out medication logs daily that document the total number of oxycodone pills taken and any other medications for pain. The data will be collected from the patients at their first postoperative visit. This will be one week postoperative.


Enrollment: 89
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126593

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

No publications provided

Responsible Party: Paula J. Harriott, Clinical Research coordinator, Orlando Health, Inc.
ClinicalTrials.gov Identifier: NCT01126593     History of Changes
Other Study ID Numbers: 708009
Study First Received: May 18, 2010
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014