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

Northwestern University

Status and phase

Completed

Phase 4

Conditions

Fracture of Ankle

Treatments

Drug: Dexamethasone

Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01616173

STU00058849

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 3 patient groups, including a placebo group

Perineural Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Intravenous Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

No Perioperative Steroids

Placebo Comparator group

Description:

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