CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 130 enrolled
Drug / intervention
Ropivacaine +4 moredrug
Likely dose
Ropivacaine 25 mlfrom 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/NCT01450007
NCT01450007Phase 4Completed

Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair

Mayo Clinic·interventional·Posted Oct 10, 2011·Updated Jun 17, 2016

In Brief

A Phase 4 clinical trial evaluating Ropivacaine, Dexamethasone, and 1 other intervention for Shoulder Injury. Completed, enrolled 130 participants across 1 site.

Detailed Summary

Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2011
Enrollment StartMay 1, 2012
Primary CompletionMay 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.7 years ago

Interventions

Ropivacainedrug

25 ml ropivacaine 0.5%

Dexamethasonedrug

8 mg dexamethasone (perineural)

Dexamethasonedrug

8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)

Normal salinedrug

5 ml normal saline (intravenous)

Normal salinedrug

0.8 ml normal saline (perineural)