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

Fracture of Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616173
• Other study ID #: STU00058849
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2012
• Last updated: November 12, 2014
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fracture of Ankle

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Opioid Consumption	Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.	2 weeks	No
Secondary	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	No