Systemic Steroids for Peripheral Nerve Blocks

Phase 4

Completed

Conditions: Osteoarthritis, Hip

Interventions: Drug: Dexamethasone
Drug: Bupivacaine
Drug: Epinephrine
Procedure: Lumbar Plexus Nerve Block
Drug: Saline

Registration Number: NCT02464176

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg dexamethasone group	Lumbar Plexus Nerve Block	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.
8 mg dexamethasone group	Lumbar Plexus Nerve Block	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.
Control Group	Lumbar Plexus Nerve Block	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.
Control Group	Saline	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.
4 mg dexamethasone group	Dexamethasone	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.
4 mg dexamethasone group	Epinephrine	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.
4 mg dexamethasone group	Bupivacaine	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.
8 mg dexamethasone group	Dexamethasone	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.
8 mg dexamethasone group	Bupivacaine	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.
8 mg dexamethasone group	Epinephrine	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.
Control Group	Bupivacaine	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.
Control Group	Epinephrine	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.

Primary Outcome Measures

Name	Time	Method
Duration of Sensory Blockade	30 hours	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.

Secondary Outcome Measures

Name	Time	Method
Time to First Analgesic Request	30 hours	Time (in minutes) will be recorded to first analgesic request following the block placement
Total Opioid Consumption	30 hours
Verbal Numeric Pain Score Comparisons	24 hour	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.