CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
Ropivacaine +2 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/NCT02462382
NCT02462382Phase 4Completed

Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks Versus Placebo for Pain Control After Arthroscopic Rotator Cuff Repair

Orlando Health, Inc.·interventional·Posted Jun 4, 2015·Updated Dec 22, 2020

In Brief

A Phase 4 clinical trial evaluating Arthroscopic Rotator Cuff Repair, Ropivacaine, and 1 other intervention for Full-thickness Rotator Cuff Tear. Completed, enrolled 51 participants across 1 site.

Detailed Summary

Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very painful when the block wears off. The purpose of this study is to: 1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair. 2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair. 3. Evaluate for any continued pain relief benefit of continuous infusion scalene block ropivacaine catheters during the three days after the infusion catheters have finished.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartSep 1, 2013
Primary CompletionMay 20, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.1 years ago

Interventions

Arthroscopic Rotator Cuff Repairprocedure

During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.

Ropivacainedrug

The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.

Salinedrug

The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.