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Systemic Steroids for Peripheral Nerve Blocks

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ClinicalTrials.gov Identifier: NCT02464176
Recruitment Status : Completed
First Posted : June 8, 2015
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Drug: Dexamethasone Drug: Bupivacaine Drug: Epinephrine Procedure: Lumbar Plexus Nerve Block Drug: Saline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block.
Study Start Date : June 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4 mg dexamethasone group
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
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.
Other Name: dexamethasone sodium phosphate injection

Drug: Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Name: Adrenaline

Procedure: Lumbar Plexus Nerve Block
This is the procedure that will be performed.

Experimental: 8 mg dexamethasone group
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
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.
Other Name: dexamethasone sodium phosphate injection

Drug: Bupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Name: Adrenaline

Procedure: Lumbar Plexus Nerve Block
This is the procedure that will be performed.

Placebo Comparator: Control Group
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
Bupivacaine will be used in lumbar plexus nerve block mixture.
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
Other Name: Adrenaline

Procedure: Lumbar Plexus Nerve Block
This is the procedure that will be performed.

Drug: Saline
Patients randomized to the placebo group will receive normal saline intravenously.
Other Name: Normal saline, NaCl




Primary Outcome Measures :
  1. Duration of Sensory Blockade [ Time Frame: 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 :
  1. Time to First Analgesic Request [ Time Frame: 30 hours ]
    Time (in minutes) will be recorded to first analgesic request following the block placement

  2. Total Opioid Consumption [ Time Frame: 30 hours ]
  3. Verbal Numeric Pain Score Comparisons [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464176


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Daryl S Henshaw, MD Wake Forest University Health Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02464176     History of Changes
Other Study ID Numbers: IRB00032805
First Posted: June 8, 2015    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018
Last Verified: November 2017

Keywords provided by Wake Forest University Health Sciences:
Arthroplasty, Hip, Replacement
Anesthesia, Local
Anesthesia Conduction
Bupivacaine
Dexamethasone
Preanesthetic Medications
Nerve Block
Lumbar Plexus Block
Analgesia
Glucocorticoids
Local Anesthetics

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Bupivacaine
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Epinephrine
Racepinephrine
Epinephryl borate
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action