Phase 4 N=60 Randomized Quadruple-blind Prevention

Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

Foot and Ankle Procedures

Bottom Line

View on ClinicalTrials.gov: NCT01975285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Postoperative Pain — 0.21; 0.05 Scores 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: Cedars-Sinai Medical Center
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain	0.21; 0.05	—
SECONDARY Opioid Consumption	0; 0	—
SECONDARY Length of Analgesia	36; 30	—
SECONDARY Patient Satisfaction With Regional Nerve Block	9.6; 9.3	—
SECONDARY Patient Satisfaction With Pain Management	9; 9.3	—

Summary

The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.

Eligibility Criteria

Inclusion Criteria

60 patients (30 per group) undergoing foot and ankle procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
American Society of Anesthesiologists (ASA)physical status Class I - III
Aged 18-90 years,either sex

Exclusion Criteria

Refusal to participate in the study
Age 90 years -
Contraindications to regional blockage including but not limited to:
Patient refusal to regional blockade
Infection at the site of needle insertion
Systemic infection
Bleeding diathesis or coagulopathy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01975285). 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.