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Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery

NCT01450007 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2016-06-17

Study results available
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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.

Conditions

  • Shoulder Injury

Interventions

DRUG

Ropivacaine

25 ml ropivacaine 0.5%

DRUG

Dexamethasone

8 mg dexamethasone (perineural)

DRUG

Dexamethasone

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

DRUG

Normal saline

5 ml normal saline (intravenous)

DRUG

Normal saline

0.8 ml normal saline (perineural)

Sponsors & Collaborators

Principal Investigators

  • David Rosenfeld, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Drugs
Companies

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 NCT01450007 on ClinicalTrials.gov