Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

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The goals of this study are as follows:

1. to confirm the safe dosing of ropivacaine for the erector spinae plane block
2. 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
3. assess numbness created by the erector spinae block when routine doses are administered

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Detailed Description

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Conditions

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Pain, Postoperative Pain, Chest

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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single

local anesthetic is delivered as a single bolus

Group Type EXPERIMENTAL

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Intervention Type DRUG

0.25% ropivacaine administered through a nerve catheter

continuous

local anesthetic is delivered as a continuous infusion

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2%-NaCl 0.9% Injectable Solution

Intervention Type DRUG

0.2% ropivacaine administered through a nerve catheter

Interventions

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Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

0.25% ropivacaine administered through a nerve catheter

Intervention Type DRUG

Ropivacaine 0.2%-NaCl 0.9% Injectable Solution

0.2% ropivacaine administered through a nerve catheter

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No