Systemic Steroids for Peripheral Nerve Blocks

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Hip

Treatments: Drug: Bupivacaine; Procedure: Lumbar Plexus Nerve Block; Drug: Dexamethasone; Drug: Saline; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02464176

IRB00032805

Details and patient eligibility

About

This study will investigate the ability of systemic dexamethasone to prolong the sensory block duration for lumbar plexus nerve blockade.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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115 participants in 3 patient groups, including a placebo group

4 mg dexamethasone group

Experimental group

Description:

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.

Treatment:

Drug: Epinephrine

Procedure: Lumbar Plexus Nerve Block

Drug: Dexamethasone

Drug: Bupivacaine

8 mg dexamethasone group

Experimental group

Description:

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.

Treatment:

Drug: Epinephrine

Procedure: Lumbar Plexus Nerve Block

Drug: Dexamethasone

Drug: Bupivacaine

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Epinephrine

Drug: Saline

Procedure: Lumbar Plexus Nerve Block

Drug: Bupivacaine