Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.

Cedars-Sinai Medical Center1 site in 1 country60 target enrollmentAugust 2013

ConditionsFoot and Ankle Procedures

InterventionsDexamethasone Saline

DrugsDexamethasone Saline

Overview

Phase: Phase 4
Intervention: Dexamethasone
Conditions: Foot and Ankle Procedures
Sponsor: Cedars-Sinai Medical Center
Enrollment: 60
Locations: 1
Primary Endpoint: Postoperative Pain
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

June 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cedars-Sinai Medical Center

Responsible Party

Principal Investigator

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

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\<18 or\> 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

Arms & Interventions

Dexamethasone group

Dexamethasone 4mg(1 ml) per 20cc

Intervention: Dexamethasone

Saline group

Saline 1 ml per 20cc

Intervention: Saline

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 3 days

Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain