Systemic Steroids for Peripheral Nerve Blocks

Study Overview
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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.

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.

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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Bupivacaine
* Drug: Epinephrine
* Procedure: Lumbar Plexus Nerve Block
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg dexamethasone group<br>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. | Drug: Dexamethasone<br>* 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.<br>* Other names: dexamethasone sodium phosphate injection;Drug: Bupivacaine<br>* Bupivacaine will be used in lumbar plexus nerve block mixture.<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Epinephrine will be used in lumbar plexus nerve block mixture.<br>* Other names: Adrenaline;Procedure: Lumbar Plexus Nerve Block<br>* This is the procedure that will be performed.<br>|
| Experimental: 8 mg dexamethasone group<br>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. | Drug: Dexamethasone<br>* 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.<br>* Other names: dexamethasone sodium phosphate injection;Drug: Bupivacaine<br>* Bupivacaine will be used in lumbar plexus nerve block mixture.<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Epinephrine will be used in lumbar plexus nerve block mixture.<br>* Other names: Adrenaline;Procedure: Lumbar Plexus Nerve Block<br>* This is the procedure that will be performed.<br>|
| Placebo Comparator: Control Group<br>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. | Drug: Bupivacaine<br>* Bupivacaine will be used in lumbar plexus nerve block mixture.<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Epinephrine will be used in lumbar plexus nerve block mixture.<br>* Other names: Adrenaline;Procedure: Lumbar Plexus Nerve Block<br>* This is the procedure that will be performed.<br>Drug: Saline<br>* Patients randomized to the placebo group will receive normal saline intravenously.<br>* Other names: Normal saline, NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Analgesic Request | Time (in minutes) will be recorded to first analgesic request following the block placement | 30 hours | 
| Total Opioid Consumption |  | 30 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Hip, Replacement, Anesthesia, Local, Anesthesia Conduction, Bupivacaine, Dexamethasone, Preanesthetic Medications, Nerve Block, Lumbar Plexus Block, Analgesia, Glucocorticoids, Local Anesthetics