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Perineural Steroids for Peripheral Nerve Blocks

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Bupivacaine
Epinephrine
Saphenous Peripheral Nerve Block
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Anesthesia, Anesthesia, Conduction, Anesthesia, Local, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block, Analgesia, Preanesthetic Medication, Perioperative Period, Peripheral Nerve Block

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • elective robotic medial MAKO partial knee arthroplasty
  • agreed to a regional anesthesia technique

Exclusion Criteria:

  • contraindications to regional anesthesia
  • presence of a progressive neurological deficit
  • a pre-existing coagulopathy, infection
  • insulin and non-insulin dependent diabetes mellitus
  • systemic use of corticosteroids within 30 days of surgery
  • chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg Oxycodone equivalents a day)
  • pregnancy
  • a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone

Sites / Locations

  • Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

4 mg Perineural Dexamethasone Group

1 mg Perineural Dexamethasone Group

Placebo Group

Arm Description

4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.

1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.

This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.

Outcomes

Primary Outcome Measures

Duration of Sensory Nerve Block
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.

Secondary Outcome Measures

Verbal Pain Scores
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.
Rate of Post Operative Nausea and Vomiting
Number of participants that experienced nausea and vomiting was recorded.
Neurologic Complications
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
Post Operative Opioid Use and Consumption
Amount of opioid use and consumption was recorded.
Time to First Opioid Analgesic Request
Time it took for the first opioid analgesic request was recorded.

Full Information

First Posted
June 1, 2015
Last Updated
September 21, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02462148
Brief Title
Perineural Steroids for Peripheral Nerve Blocks
Official Title
Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
Detailed Description
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Anesthesia, Anesthesia, Conduction, Anesthesia, Local, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block, Analgesia, Preanesthetic Medication, Perioperative Period, Peripheral Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 mg Perineural Dexamethasone Group
Arm Type
Experimental
Arm Description
4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Arm Title
1 mg Perineural Dexamethasone Group
Arm Type
Experimental
Arm Description
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexamethasone Sodium Phosphate Injection
Intervention Description
Used in nerve block mixture
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Used in nerve block mixture
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
Adrenaline
Intervention Description
Used in nerve block mixture
Intervention Type
Procedure
Intervention Name(s)
Saphenous Peripheral Nerve Block
Other Intervention Name(s)
Adductor Canal Peripheral Nerve Block
Intervention Description
Peripheral nerve block.
Primary Outcome Measure Information:
Title
Duration of Sensory Nerve Block
Description
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
Time Frame
12 to 48 hours
Secondary Outcome Measure Information:
Title
Verbal Pain Scores
Description
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.
Time Frame
0 to 30 hours
Title
Rate of Post Operative Nausea and Vomiting
Description
Number of participants that experienced nausea and vomiting was recorded.
Time Frame
0 to 30 hours
Title
Neurologic Complications
Description
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
Time Frame
throughout study completion, up to 48 hours
Title
Post Operative Opioid Use and Consumption
Description
Amount of opioid use and consumption was recorded.
Time Frame
0-30 hours
Title
Time to First Opioid Analgesic Request
Description
Time it took for the first opioid analgesic request was recorded.
Time Frame
0 to 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: elective robotic medial MAKO partial knee arthroplasty agreed to a regional anesthesia technique Exclusion Criteria: contraindications to regional anesthesia presence of a progressive neurological deficit a pre-existing coagulopathy, infection insulin and non-insulin dependent diabetes mellitus systemic use of corticosteroids within 30 days of surgery chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg Oxycodone equivalents a day) pregnancy a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl S Henshaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29753264
Citation
Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9.
Results Reference
derived

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Perineural Steroids for Peripheral Nerve Blocks

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