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Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.5% bupivacaine
Normal Saline
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orlando Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

No Intervention

Experimental

Arm Label

Placebo group

Control group

Study Group

Arm Description

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.

The control group patients will receive no continuous infusion catheter.

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.

Outcomes

Primary Outcome Measures

Pain Scores
Pain was measured via Visual Analong Scale in measurement (0-100mm).

Secondary Outcome Measures

Full Information

First Posted
May 18, 2010
Last Updated
November 6, 2014
Sponsor
Orlando Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01126593
Brief Title
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Official Title
Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group patients will receive no continuous infusion catheter.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.5% bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Saline
Intervention Description
The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Pain was measured via Visual Analong Scale in measurement (0-100mm).
Time Frame
O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Schwartzberg, MD
Organizational Affiliation
Orlando Orthopaedic Center and Orlando Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Orthopaedic Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

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Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

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