CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Interscalene Block (ISB) - 0.375% Ropivacaine + additives +3 moreprocedure
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/NCT01782872
NCT01782872Phase 4Completed
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Analgesia After Total Shoulder Arthroplasty

Hospital for Special Surgery, New York·interventional·Posted Feb 4, 2013·Updated May 18, 2016

In Brief

A Phase 4 clinical trial evaluating Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives, and 2 other interventions for Total Shoulder Arthroplasty. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic \[numbing medicine\] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Shoulder Arthroplasty
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2013
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2014
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago

Interventions

Interscalene Block (ISB) - 0.375% Ropivacaine + additivesprocedure

Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline

Interscalene Block (ISB) - 0.2% Ropivacaine + additivesprocedure

Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline

Interscalene Block (ISB) - 0.1% Ropivacaine + additivesprocedure

Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline

Interscalene Block (ISB) - Systemic Controlprocedure

Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)