Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine

July 14, 2015 updated by: Sangjin Park, Yeungnam University College of Medicine

Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery

The aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In a double-blinded trial utilizing single-injection sciatic nerve block, patients are randomly assigned to one of three groups: control: 0.5% ropivacaine adding normal saline; epinephrine: 0.5% ropivacaine adding epinephrine; dexamethasone: 0.5% ropivacaine adding dexamethasone. We assess time to first analgesic request after post-anaesthesia care unit discharge.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-035
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
        • Contact:
        • Principal Investigator:
          • Sangjin Park, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I and II
  • patients undergoing elective hallux valgus repair

Exclusion Criteria:

  • patients receiving chronic analgesic therapy
  • diabetes
  • peripheral neuropathies
  • psychiatric disorders
  • hypersensitivity to amide local anesthetics
  • renal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Drug: Dexamethasone
In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Placebo Comparator: Control
Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Experimental: epinephrine
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Drug: Epinephrine
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first analgesic request after postanesthetic care unit discharge
Time Frame: from arrival in postanesthetic care unit to 72 hours after operation
A blinded observer interview patients at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
from arrival in postanesthetic care unit to 72 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of recovery of motor and sensory functions on the operated foot
Time Frame: from arrival in postanesthetic care unit to 72 hours after operation
The time of recovery of motor (ability to move the ankle) and sensory (recovery of normal pinprick sensation) functions on the operated foot is recorded by the blinded observer at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
from arrival in postanesthetic care unit to 72 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeungnam University College of Medicine

Investigators

  • Principal Investigator: Sangjin Park, M.D., Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • apsj20140401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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