CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
0.5% bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01126593
NCT01126593N/ACompleted
CompareCT.gov

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

Orlando Health, Inc.·interventional·Posted May 19, 2010·Updated Nov 7, 2014

In Brief

A clinical study evaluating 0.5% bupivacaine and Normal Saline for Rotator Cuff Tear. Completed, enrolled 96 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotator Cuff Tear
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2010
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.1 years ago

Interventions

0.5% bupivacainedrug

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.

Normal Salinedrug

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