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

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture of Ankle
• Intervention / Treatment: Drug: Dexamethasone; Drug: Dexamethasone; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; IV dexamethsone 8mg in 50mL (diluted in NS); Other Names: DECADRON; Drug: Dexamethasone; 8mg/2mL; Other Names: 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 Names: DECADRON; Drug: Dexamethasone; 8mg/2mL; Other Names: 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 Names: Sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.	2 weeks
Pain Scores	Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).	2 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Rohit Rahangdale, MD, Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (ESTIMATE): June 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Nerve Block; Anesthesia Recovery Period
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Ankle Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: STU00058849