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

Overview

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.

Full Title of Study: “The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2013

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.

Interventions

  • Drug: Dexamethasone
    • IV dexamethsone 8mg in 50mL (diluted in NS)
  • Drug: Dexamethasone
    • 8mg/2mL
  • Drug: Saline
    • 2mL

Arms, Groups and Cohorts

  • 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
  • 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
  • Placebo Comparator: No Perioperative Steroids
    • Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion

Clinical Trial Outcome Measures

Primary 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 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rohit Rahangdale, Assistant Professor of Anesthesiology – Northwestern University
  • Overall Official(s)
    • Rohit Rahangdale, MD, Principal Investigator, Northwestern University Feinberg School of Medicine

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