Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

Phase 4

Withdrawn

• Conditions: Pain, Chest; Pain, Postoperative
• Interventions: Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution; Drug: Ropivacaine 0.2%-NaCl 0.9% Injectable Solution

• Registration Number: NCT03874806
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Status Verified: 2019-07
• Study Start: 2019-07-01
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
single	Ropivacaine 0.25%-NaCl 0.9% Injectable Solution	local anesthetic is delivered as a single bolus
continuous	Ropivacaine 0.2%-NaCl 0.9% Injectable Solution	local anesthetic is delivered as a continuous infusion

Primary Outcome Measures

Name	Time	Method
Cmax	28 hours	The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Area of analgesia	4 hours	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	4 hours	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
Tmax	28 hours	The time elapsed from initial ropivacaine administration to Cmax

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States