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

NCT ID: NCT01975285

Last Updated: 2016-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Foot and Ankle Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone group

Dexamethasone 4mg(1 ml) per 20cc

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Saline group

Saline 1 ml per 20cc

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Decadron placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roya Yumul, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00032547

Identifier Type: -

Identifier Source: org_study_id

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