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Analgesia After Total Shoulder Arthroplasty

NCT01782872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-18

Study results available
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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.

Conditions

  • Total Shoulder Arthroplasty

Interventions

PROCEDURE

Interscalene Block (ISB) - 0.375% Ropivacaine + additives

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

PROCEDURE

Interscalene Block (ISB) - 0.2% Ropivacaine + additives

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

PROCEDURE

Interscalene Block (ISB) - 0.1% Ropivacaine + additives

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

PROCEDURE

Interscalene Block (ISB) - Systemic Control

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

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Jacques T YaDeau, MD, PhD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01782872 on ClinicalTrials.gov