Systemic Steroids for Peripheral Nerve Blocks

July 31, 2018 updated by: Wake Forest University Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 mg dexamethasone group
Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
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.
Other Names:
  • dexamethasone sodium phosphate injection
Drug: Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Adrenaline
Procedure: Lumbar Plexus Nerve Block
This is the procedure that will be performed.
Experimental: 8 mg dexamethasone group
Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
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.
Other Names:
  • dexamethasone sodium phosphate injection
Drug: Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Adrenaline
Procedure: Lumbar Plexus Nerve Block
This is the procedure that will be performed.
Placebo Comparator: Control Group
Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.
Drug: Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Names:
  • Adrenaline
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.
Other Names:
  • Normal saline, NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Analgesic Request
Time Frame: 30 hours
Time (in minutes) will be recorded to first analgesic request following the block placement
30 hours
Total Opioid Consumption
Time Frame: 30 hours
30 hours
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.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00032805

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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