Perineural Steroids for Peripheral Nerve Blocks

September 21, 2018 updated by: Wake Forest University Health Sciences

Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.

This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 mg Perineural Dexamethasone Group
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.
Drug: Dexamethasone
Used in nerve block mixture
Other Names:
  • Dexamethasone Sodium Phosphate Injection
Drug: Bupivacaine
Used in nerve block mixture
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Used in nerve block mixture
Other Names:
  • Adrenaline
Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Names:
  • Adductor Canal Peripheral Nerve Block
Experimental: 1 mg Perineural Dexamethasone Group
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.
Drug: Dexamethasone
Used in nerve block mixture
Other Names:
  • Dexamethasone Sodium Phosphate Injection
Drug: Bupivacaine
Used in nerve block mixture
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Used in nerve block mixture
Other Names:
  • Adrenaline
Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Names:
  • Adductor Canal Peripheral Nerve Block
Placebo Comparator: Placebo Group
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.
Drug: Bupivacaine
Used in nerve block mixture
Other Names:
  • Bupivacaine Hydrochloride
Drug: Epinephrine
Used in nerve block mixture
Other Names:
  • Adrenaline
Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Names:
  • Adductor Canal Peripheral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Sensory Nerve Block
Time Frame: 12 to 48 hours
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.
12 to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Pain Scores
Time Frame: 0 to 30 hours
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.
0 to 30 hours
Rate of Post Operative Nausea and Vomiting
Time Frame: 0 to 30 hours
Number of participants that experienced nausea and vomiting was recorded.
0 to 30 hours
Neurologic Complications
Time Frame: throughout study completion, up to 48 hours
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
throughout study completion, up to 48 hours
Post Operative Opioid Use and Consumption
Time Frame: 0-30 hours
Amount of opioid use and consumption was recorded.
0-30 hours
Time to First Opioid Analgesic Request
Time Frame: 0 to 36 hours
Time it took for the first opioid analgesic request was recorded.
0 to 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00032807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe