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Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

This study is currently recruiting participants.
Verified June 2012 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Rohit Rahangdale, Northwestern University
ClinicalTrials.gov Identifier:
NCT01616173
First received: June 6, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.


Condition Intervention Phase
Ankle Surgery
 Drug: Dexamethasone
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of recovery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • VRS pain scores [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Perineural Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg in 4mL, and 50mL IV normal saline infusion
 Drug: Dexamethasone
8mg in 4mL
Active Comparator: Intravenous Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline (4mL) and IV dexamethsone 8mg in 50mL infusion
 Drug: Dexamethasone
IV dexamethsone 8mg in 50mL (diluted in NS)
Placebo Comparator: No Perioperative Steroids
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline (4mL) and 50mL infusion
 Drug: Saline
4mL

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
  • Surgery confined to the foot and ankle.
  • Patients aged 18-70 years.

Exclusion Criteria:

  • ASA Classification of 4 or higher.
  • Pre-existing neuropathy
  • Coagulopathy
  • Infection at the site
  • Diabetes
  • Non-English speaking or reading patients
  • Systemic use of corticosteroids within 6 months of surgery
  • Chronic opioid use
  • Pregnancy
  • Large (>3cm) skin incision around the medial aspect of the foot
  • Any other contra-indication to regional anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616173

Contacts
Contact: Rohit Rahangdale, MD 312/926-2280 r-rahangdale@northwestern.edu

Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Rohit Rahandgale, MD     312-926-2280     r-rahangdale@northwestern.edu    
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Rohit Rahangdale, Assistant Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01616173     History of Changes
Other Study ID Numbers: STU00058849
Study First Received: June 6, 2012
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Nerve Block
Anesthesia Recovery Period

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
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

ClinicalTrials.gov processed this record on May 22, 2013