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Systemic Steroids for Peripheral Nerve Blocks

Primary Purpose

Osteoarthritis, Hip

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Bupivacaine

Epinephrine

Lumbar Plexus Nerve Block

Saline

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Arthroplasty, Hip, Replacement, Anesthesia, Local, Anesthesia Conduction, Bupivacaine, Dexamethasone, Preanesthetic Medications, Nerve Block, Lumbar Plexus Block, Analgesia, Glucocorticoids, Local Anesthetics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

4 mg dexamethasone group

8 mg dexamethasone group

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to First Analgesic Request

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

Total Opioid Consumption

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.

Full Information

NCT ID

NCT02464176

First Posted

June 1, 2015

Last Updated

July 31, 2018

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02464176

Brief Title

Systemic Steroids for Peripheral Nerve Blocks

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip

Keywords

Arthroplasty, Hip, Replacement, Anesthesia, Local, Anesthesia Conduction, Bupivacaine, Dexamethasone, Preanesthetic Medications, Nerve Block, Lumbar Plexus Block, Analgesia, Glucocorticoids, Local Anesthetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4 mg dexamethasone group

Arm Type

Experimental

Arm Description

Arm Title

8 mg dexamethasone group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

dexamethasone sodium phosphate injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Bupivacaine Hydrochloride

Intervention Description

Bupivacaine will be used in lumbar plexus nerve block mixture.

Intervention Type

Drug

Intervention Name(s)

Epinephrine

Other Intervention Name(s)

Adrenaline

Intervention Description

Epinephrine will be used in lumbar plexus nerve block mixture.

Intervention Type

Procedure

Intervention Name(s)

Lumbar Plexus Nerve Block

Intervention Description

This is the procedure that will be performed.

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Normal saline, NaCl

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of Sensory Blockade

Description

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 Outcome Measure Information:

Title

Time to First Analgesic Request

Description

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

Time Frame

30 hours

Title

Total Opioid Consumption

Time Frame

30 hours

Title

Verbal Numeric Pain Score Comparisons

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daryl S Henshaw, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29406180

Citation

Turner JD, Dobson SW, Weller RS, Russell GB, Henshaw DS. Intravenous dexamethasone fails to prolong psoas compartment block when assessed by objective pinprick sensory testing: a prospective, randomised, dose-dependent, placebo-controlled equivalency trial. Br J Anaesth. 2018 Feb;120(2):308-316. doi: 10.1016/j.bja.2017.11.073. Epub 2017 Dec 1.

Results Reference

derived

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Systemic Steroids for Peripheral Nerve Blocks

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