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OpenTrials
Completed

NCT Number: NCT01616173

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

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.

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Key information

Conditions

Fracture of Ankle Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

IV dexamethsone 8mg in 50mL (diluted in NS)

Other names: DECADRON

Saline

Drug

2mL

Other names: Sodium chloride

Primary outcomes

  1. 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 outcomes

  1. Opioid Consumption

    Time frame: 2 weeks

    Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.

  2. 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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