The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

This study has been terminated.
(PI is no longer here.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616603
First received: February 4, 2008
Last updated: June 10, 2014
Last verified: June 2014
  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:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Duration of Sciatic Nerve Block [ Time Frame: from the time the block was placed up to 24 hours ] [ Designated as safety issue: No ]
    Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores


Enrollment: 43
Study Start Date: August 2007
Study Completion Date: May 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616603     History of Changes
Other Study ID Numbers: 57164
Study First Received: February 4, 2008
Results First Received: May 17, 2013
Last Updated: June 10, 2014
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 July 24, 2014