Phase 4 N=80 Randomized Triple-blind Supportive Care

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

Fracture of Ankle

Bottom Line

View on ClinicalTrials.gov: NCT01616173 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Quality of Recovery — 181; 184; 181 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Quality of Recovery	181; 184; 181	—
SECONDARY Opioid Consumption	0; 0; 0	—
SECONDARY Pain Scores	2; 2.5; 2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01616173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.