Skip to main content
OpenTrials
Completed

NCT Number: NCT02464176

Systemic Steroids for Peripheral Nerve Blocks

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Hip Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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.

Other names: dexamethasone sodium phosphate injection

Bupivacaine

Drug

Bupivacaine will be used in lumbar plexus nerve block mixture.

Other names: Bupivacaine Hydrochloride

Epinephrine

Drug

Epinephrine will be used in lumbar plexus nerve block mixture.

Other names: Adrenaline

Lumbar Plexus Nerve Block

Procedure

This is the procedure that will be performed.

Saline

Drug

Patients randomized to the placebo group will receive normal saline intravenously.

Other names: Normal saline, NaCl

Primary outcomes

  1. Duration of Sensory Blockade

    Time frame: 30 hours

    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.

Secondary outcomes

  1. Time to First Analgesic Request

    Time frame: 30 hours

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

  2. Total Opioid Consumption

    Time frame: 30 hours

  3. Verbal Numeric Pain Score Comparisons

    Time frame: 24 hour

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.