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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02104778
• Other study ID #: apsj20140401
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2014
• Last updated: July 14, 2015
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2015
• Source: Yeungnam University College of Medicine
• Contact: Sangjin Park, M.D.
• Phone: 82-53-620-3366
• Email: apsj0718[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
• Epinephrine
Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from arrival in postanesthetic care unit to 72 hours after operation	No
Secondary	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.	from arrival in postanesthetic care unit to 72 hours after operation	No