The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks - Full Text View

Purpose

Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.

Condition	Intervention
Total Knee Arthroplasty	Drug: Ropivacaine Drug: Dexamethasone Drug: Normal Saline

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

Duration of Sciatic Nerve Block [ Time Frame: 24-48 hrs following placement of the block. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total opioid requirement. [ Time Frame: 24-48 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	August 2007
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.	Drug: Ropivacaine 20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once. Drug: Normal Saline 2ml of normal saline given once intravenously.
Experimental: Group B Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.	Drug: Ropivacaine 20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once. Drug: Dexamethasone 8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once. Drug: Normal Saline 2ml of normal saline given once intravenously.
Active Comparator: Group C Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.	Drug: Ropivacaine 20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once. Drug: Dexamethasone 2ml(8mg)Dexamethasone given once intravenously.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-80 yrs, male or female subjects.
Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
American Society of Anesthesiology Class 1,2,3,or 4.
Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
Weight > or equal to 60kg.

Exclusion Criteria:

Any allergies or hypersensitivity to ropivacaine or dexamethasone.
Subject is on chronic steroids preoperatively for any reason.
History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
Contraindication to placement of sciatic nerve block.
Sciatic block placement failure.
Subject mistakenly receives steroids intraoperatively.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616603

Locations

United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator:

Charles Lee, M.D.

Loma Linda University Medical Center

More Information

No publications provided

Responsible Party:	Charles Lee, M.D., Loma Linda University Medical Center Department of Anesthesia
ClinicalTrials.gov Identifier:	NCT00616603 History of Changes
Other Study ID Numbers:	57164
Study First Received:	February 4, 2008
Last Updated:	September 9, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:

Total Knee Arthroplasty.
Sciatic nerve Blocks.
Dexamethasone.

Additional relevant MeSH terms:

Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

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
Sensory System Agents

ClinicalTrials.gov processed this record on June 17, 2013