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

Phase 4CompletedNCT01975285

Cedars-Sinai Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Foot and Ankle Procedures

Interventions

DexamethasoneDRUG

0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc

SalineDRUG

0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cedars Sinai Medical center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Postoperative Pain

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

Time frame: 3 days

Secondary Outcomes

Opioid Consumption

Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)

Time frame: 3 days

Length of Analgesia

Time in days and/or hours

Time frame: 3 days

Patient Satisfaction With Regional Nerve Block

Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

Time frame: 3 days

Patient Satisfaction With Pain Management

Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

Time frame: 3 days

Data from ClinicalTrials.gov

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