Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

NCT01126593 | Completed Results DMC

• 1 other identifier: 708009
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Control group

NO INTERVENTION

The control group patients will receive no continuous infusion catheter.

Study Group

EXPERIMENTAL

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

Interventions

0.5% bupivacaine DRUG

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.

Also known as: Marcaine

Study Group

Normal Saline DRUG

The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.

Also known as: Saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Orthopaedic Center

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

It is possible that different catheter infusion rates, different bupivacaine concentrations, and pain modulation agents different from bupivacaine could result in different findings.

Results Point of Contact

• Title: Dr. Randy Schwartzberg
• Organization: Orlando Orthopaedic Center

orlandosportsdoc@yahoo.com

(407) 254-2500

Study Officials

• Randy Schwartzberg, MD

  Orlando Orthopaedic Center and Orlando Health, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon, Orlando Orthopaedic Center

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 19, 2010
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 7, 2014
• Results First Posted: November 7, 2014

Record last verified: 2014-11

Locations

US (1)