Systemic Steroids for Peripheral Nerve Blocks

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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

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Detailed Description

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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

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

Bupivacaine

Intervention Type DRUG

Bupivacaine will be used in lumbar plexus nerve block mixture.

Epinephrine

Intervention Type DRUG

Epinephrine will be used in lumbar plexus nerve block mixture.

Lumbar Plexus Nerve Block

Intervention Type PROCEDURE

This is the procedure that will be performed.

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type 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.

Bupivacaine

Intervention Type DRUG

Bupivacaine will be used in lumbar plexus nerve block mixture.

Epinephrine

Intervention Type DRUG

Epinephrine will be used in lumbar plexus nerve block mixture.

Lumbar Plexus Nerve Block

Intervention Type PROCEDURE

This is the procedure that will be performed.

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.

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine will be used in lumbar plexus nerve block mixture.

Epinephrine

Intervention Type DRUG

Epinephrine will be used in lumbar plexus nerve block mixture.

Lumbar Plexus Nerve Block

Intervention Type PROCEDURE

This is the procedure that will be performed.

Saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Bupivacaine

Bupivacaine will be used in lumbar plexus nerve block mixture.

Intervention Type DRUG

Epinephrine

Epinephrine will be used in lumbar plexus nerve block mixture.

Intervention Type DRUG

Lumbar Plexus Nerve Block

This is the procedure that will be performed.

Intervention Type PROCEDURE

Saline

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

Intervention Type DRUG

Other Intervention Names

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dexamethasone sodium phosphate injection Bupivacaine Hydrochloride Adrenaline Normal saline, NaCl

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes