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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616173
First Posted: June 11, 2012
Last Update Posted: November 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rohit Rahangdale, Northwestern University
  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
Fracture of Ankle Drug: Dexamethasone Drug: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes

Resource links provided by NLM:


Further study details as provided by Rohit Rahangdale, Northwestern University:

Primary Outcome Measures:
  • Quality of Recovery [ Time Frame: 2 weeks ]
    QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.


Secondary Outcome Measures:
  • Opioid Consumption [ Time Frame: 2 weeks ]
    Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.

  • Pain Scores [ Time Frame: 2 weeks ]
    Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).


Enrollment: 80
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: February 2013 (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/2mL, and 50mL IV normal saline infusion
Drug: Dexamethasone
8mg/2mL
Other Name: DECADRON
Active Comparator: Intravenous Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion
Drug: Dexamethasone
IV dexamethsone 8mg in 50mL (diluted in NS)
Other Name: DECADRON
Placebo Comparator: No Perioperative Steroids
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion
Drug: Saline
2mL
Other Name: Sodium chloride

Detailed Description:
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. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01616173


Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Rohit Rahangdale, MD Northwestern University Feinberg School of Medicine
  More Information

Responsible Party: Rohit Rahangdale, Assistant Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01616173     History of Changes
Other Study ID Numbers: STU00058849
First Submitted: June 6, 2012
First Posted: June 11, 2012
Results First Submitted: September 18, 2014
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Rohit Rahangdale, Northwestern University:
Nerve Block
Anesthesia Recovery Period

Additional relevant MeSH terms:
Ankle Fractures
Fractures, Bone
Wounds and Injuries
Dexamethasone acetate
Dexamethasone
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