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

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ClinicalTrials.gov Identifier: NCT02104778
Recruitment Status : Unknown
Verified July 2015 by Sangjin Park, Yeungnam University College of Medicine.
Recruitment status was:  Recruiting
First Posted : April 4, 2014
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Sangjin Park, Yeungnam University College of Medicine

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Epinephrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine in Ankle and Foot Surgery
Study Start Date : April 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104778


Contacts
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Contact: Sangjin Park, M.D. 82-53-620-3366 apsj0718@naver.com

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital Recruiting
Daegu, Korea, Republic of, 705-035
Contact: Duckhee Lee, M.D.    82-53-620-3365    apsj0718@naver.com   
Principal Investigator: Sangjin Park, M.D.         
Sponsors and Collaborators
Yeungnam University College of Medicine
Investigators
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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

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Responsible Party: Sangjin Park, assistant professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT02104778     History of Changes
Other Study ID Numbers: apsj20140401
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Epinephrine
Racepinephrine
Ropivacaine
Epinephryl borate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants