Systemic Steroids for Peripheral Nerve Blocks

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464176
• Other study ID #: IRB00032805
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

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