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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Epinephrine
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yeungnam University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Dexamethasone

Control

epinephrine

Arm Description

Dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Outcomes

Primary Outcome Measures

time to first analgesic request after postanesthetic care unit discharge
A blinded observer interview patients at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.

Secondary Outcome Measures

time of recovery of motor and sensory functions on the operated foot
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.

Full Information

First Posted
April 1, 2014
Last Updated
July 14, 2015
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02104778
Brief Title
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine
Official Title
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Arm Title
epinephrine
Arm Type
Experimental
Arm Description
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block
Primary Outcome Measure Information:
Title
time to first analgesic request after postanesthetic care unit discharge
Description
A blinded observer interview patients at arrival in postanesthetic care unit, 6 hour, 24 hour, 48 hour, 72 hour after operation.
Time Frame
from arrival in postanesthetic care unit to 72 hours after operation
Secondary Outcome Measure Information:
Title
time of recovery of motor and sensory functions on the operated foot
Description
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.
Time Frame
from arrival in postanesthetic care unit to 72 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangjin Park, M.D.
Phone
82-53-620-3366
Email
apsj0718@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangjin Park, M.D.
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
City
Daegu
ZIP/Postal Code
705-035
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duckhee Lee, M.D.
Phone
82-53-620-3365
Email
apsj0718@naver.com
First Name & Middle Initial & Last Name & Degree
Sangjin Park, M.D.

12. IPD Sharing Statement

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

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