NCT02464176

Systemic Steroids for Peripheral Nerve Blocks

The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the ability of systemic dexamethasone to prolong the sensory block duration for lumbar plexus nerve blockade.

Detailed description

The purpose of this randomized, double-blinded, placebo-controlled trial is to examine the equivalency of two different doses of dexamethasone when given intravenously as an adjuvant medication for postoperative pain management. Specifically, this study will investigate the prolongation of time to recovery of sensation following a lumbar plexus block in patients undergoing total hip arthroplasties. The investigators hypothesize that dexamethasone will prolong the sensory block time when compared to placebo and that similar results will be obtained in the 4 mg arm when compared to the 8 mg arm. The primary end point will be time to sensory recovery in the femoral nerve cutaneous distribution (part of the lumbar plexus) as determined by pin-prick sensation assessment. Secondary endpoints will include, but are not be limited to: time to first opioid administration, total opioid consumption over 30 hours, and rest and incident verbal numerical pain scores at 6,12,18,24 and 30 hours post block placement.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	Dexamethasone	A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken at that same site over the course of the study. The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.
DRUG	Bupivacaine	Bupivacaine will be used in lumbar plexus nerve block mixture.
DRUG	Epinephrine	Epinephrine will be used in lumbar plexus nerve block mixture.
PROCEDURE	Lumbar Plexus Nerve Block	This is the procedure that will be performed.
DRUG	Saline	Patients randomized to the placebo group will receive normal saline intravenously.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-06-08
• Last updated: 2018-08-31
• Results posted: 2018-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study