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Completed

NCT Number: NCT01126593

Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Orthopaedic Center

Orlando, Florida, 32806, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Marcaine

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.

Other names: Saline

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 19, 2010
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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