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

Phase 4

Completed

• Conditions: Foot and Ankle Procedures
• Interventions: Drug: Saline; Drug: Dexamethasone

• Registration Number: NCT01975285
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2016-01-26
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-06
• Last Update Submitted: 2016-04-06
• Results First Posted: 2016-05-06
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline group	Saline	Saline 1 ml per 20cc
Dexamethasone group	Dexamethasone	Dexamethasone 4mg(1 ml) per 20cc

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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

Secondary Outcome Measures

Name	Time	Method
Length of Analgesia	3 days	Time in days and/or hours
Patient Satisfaction With Pain Management	3 days	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
Patient Satisfaction With Regional Nerve Block	3 days	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
Opioid Consumption	3 days	Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)

Trial Locations

Locations (1)

Cedars Sinai Medical center; 🇺🇸 Los Angeles, California, United States