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Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

Primary Purpose

Pain, Postoperative, Pain, Chest

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
Ropivacaine 0.2%-NaCl 0.9% Injectable Solution
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participant's age is greater than 18 years
  2. Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
  3. Participant's surgery is being performed by Dr. Vig Kasirajan

Exclusion Criteria:

  1. Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
  2. Abnormal liver function tests demonstrated by lab results
  3. Allergy to lidocaine, ropivacaine, or midazolam
  4. Morbid obesity, defined as body mass index greater than 40
  5. Existing skin neuropathy on the chest or back
  6. Body weight less than 50 kg
  7. Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation
  8. Participant remains intubated on post-operative day 1
  9. Pregnant women

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

single

continuous

Arm Description

local anesthetic is delivered as a single bolus

local anesthetic is delivered as a continuous infusion

Outcomes

Primary Outcome Measures

Cmax
The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Tmax
The time elapsed from initial ropivacaine administration to Cmax
Area of analgesia
The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Duration of analgesia
The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness

Secondary Outcome Measures

Full Information

First Posted
March 8, 2019
Last Updated
July 11, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03874806
Brief Title
Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block
Official Title
Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Did not receive funding
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goals of this study are as follows: to confirm the safe dosing of ropivacaine for the erector spinae plane block develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block assess numbness created by the erector spinae block when routine doses are administered

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Chest

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single
Arm Type
Experimental
Arm Description
local anesthetic is delivered as a single bolus
Arm Title
continuous
Arm Type
Active Comparator
Arm Description
local anesthetic is delivered as a continuous infusion
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
Intervention Description
0.25% ropivacaine administered through a nerve catheter
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2%-NaCl 0.9% Injectable Solution
Intervention Description
0.2% ropivacaine administered through a nerve catheter
Primary Outcome Measure Information:
Title
Cmax
Description
The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Time Frame
28 hours
Title
Tmax
Description
The time elapsed from initial ropivacaine administration to Cmax
Time Frame
28 hours
Title
Area of analgesia
Description
The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Time Frame
4 hours
Title
Duration of analgesia
Description
The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant's age is greater than 18 years Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision Participant's surgery is being performed by Dr. Vig Kasirajan Exclusion Criteria: Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis Abnormal liver function tests demonstrated by lab results Allergy to lidocaine, ropivacaine, or midazolam Morbid obesity, defined as body mass index greater than 40 Existing skin neuropathy on the chest or back Body weight less than 50 kg Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation Participant remains intubated on post-operative day 1 Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryant Tran, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

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