Systemic Steroids for Peripheral Nerve Blocks

Wake Forest University Health Sciences115 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

115

Conditions

Osteoarthritis, Hip

Interventions

DexamethasoneDRUG

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.

BupivacaineDRUG

Bupivacaine will be used in lumbar plexus nerve block mixture.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Primary elective total hip arthroplasty surgery * must be a candidate for placement of a lumbar plexus block under anatomic landmark technique using electrical stimulation * must give written informed consent for anesthesia * must also be reliable and able to give accurate verbal pain scores postoperatively Exclusion Criteria: * contraindications to regional anesthesia including, allergy to amide local anesthetics, presence of peripheral neurologic dysfunction, pre-existing coagulopathy or infection in the area of interest will be excluded. * insulin and non-insulin dependent diabetes mellitus * preoperative use of systemic corticosteroids within 30 days of surgery * chronic opioid use (defined as daily opioid dose of greater than 40 mg of oxycodone equivalents or any long-acting opioid) * pregnancy * failure to effectively place the lumbar plexus block. * known prior adverse reaction to dexamethasone (for example: psychosis) or an allergy to dexamethasone

Locations (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Duration of Sensory Blockade

The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation.

Time frame: 30 hours

Secondary Outcomes

Time to First Analgesic Request

Time (in minutes) will be recorded to first analgesic request following the block placement

Time frame: 30 hours

Total Opioid Consumption

Time frame: 30 hours

Verbal Numeric Pain Score Comparisons

This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better.

Time frame: 24 hour

Data from ClinicalTrials.gov

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