Systemic Steroids for Peripheral Nerve Blocks
The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block.
1 other identifier
interventional
115
1 country
1
Brief Summary
This study will investigate the ability of systemic dexamethasone to prolong the sensory block duration for lumbar plexus nerve blockade.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
January 16, 2018
CompletedAugust 31, 2018
July 1, 2018
1.6 years
June 1, 2015
November 15, 2017
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Time to First Analgesic Request
30 hours
Total Opioid Consumption
30 hours
Verbal Numeric Pain Score Comparisons
24 hour
Study Arms (3)
4 mg dexamethasone group
EXPERIMENTALFollowing 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.
8 mg dexamethasone group
EXPERIMENTALFollowing 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.
Control Group
PLACEBO COMPARATORNormal 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.
Interventions
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 will be used in lumbar plexus nerve block mixture.
Epinephrine will be used in lumbar plexus nerve block mixture.
This is the procedure that will be performed.
Patients randomized to the placebo group will receive normal saline intravenously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
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.
PMID: 29406180DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. James D. Turner
- Organization
- Wake Forest Baptist Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Daryl S Henshaw, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
August 31, 2018
Results First Posted
January 16, 2018
Record last verified: 2018-07