Clinical trial NCT02464176: Systemic Steroids for Peripheral Nerve Blocks
Official title: The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Keywords: Arthroplasty, Hip, Replacement
Anesthesia, Local
Anesthesia Conduction
Bupivacaine
Dexamethasone
Preanesthetic Medications
Nerve Block
Lumbar Plexus Block
Analgesia
Glucocorticoids
Local Anesthetics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Sensory Blockade
timeFrame: 30 hours
Secondary outcomes:
measure: Time to First Analgesic Request
timeFrame: 30 hours
measure: Total Opioid Consumption
timeFrame: 30 hours
measure: Verbal Numeric Pain Score Comparisons
timeFrame: 24 hour
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Daryl S Henshaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.