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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02464176
Other study ID # IRB00032805
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2015
Est. completion date January 2017

Study information

Verified date July 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
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.

Locations

Country Name City State
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 hours
Secondary Time to First Analgesic Request Time (in minutes) will be recorded to first analgesic request following the block placement 30 hours
Secondary Total Opioid Consumption 30 hours
Secondary 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. 24 hour
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