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

NCT02104778 | Unknown DMC

• 1 other identifier: apsj20140401
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  from arrival in postanesthetic care unit to 72 hours after operation

Study Arms (3)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Control

PLACEBO COMPARATOR

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

epinephrine

EXPERIMENTAL

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

Drug: Epinephrine

Interventions

Dexamethasone DRUG

In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Dexamethasone

Epinephrine DRUG

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

epinephrine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, 705-035, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sangjin Park, M.D.

  Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangjin Park, M.D.

CONTACT

82-53-620-3366; apsj0718@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

KR (1)