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Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

NCT ID: NCT01616173

Last Updated: 2014-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.

Detailed Description

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Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

Conditions

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Fracture of Ankle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Perineural Dexamethasone

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

8mg/2mL

Intravenous Dexamethasone

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

IV dexamethsone 8mg in 50mL (diluted in NS)

No Perioperative Steroids

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2mL

Interventions

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Dexamethasone

IV dexamethsone 8mg in 50mL (diluted in NS)

Intervention Type DRUG

Dexamethasone

8mg/2mL

Intervention Type DRUG

Saline

2mL

Intervention Type DRUG

Other Intervention Names

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DECADRON DECADRON Sodium chloride

Eligibility Criteria

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Inclusion Criteria

* ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
* Surgery confined to the foot and ankle.
* Patients aged 18-70 years.

Exclusion Criteria

* ASA Classification of 4 or higher.
* Pre-existing neuropathy
* Coagulopathy
* Infection at the site
* Diabetes
* Non-English speaking or reading patients
* Systemic use of corticosteroids within 6 months of surgery
* Chronic opioid use
* Pregnancy
* Large (\>3cm) skin incision around the medial aspect of the foot
* Any other contra-indication to regional anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Rohit Rahangdale

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rohit Rahangdale, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00058849

Identifier Type: -

Identifier Source: org_study_id