Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

Pain, Postoperative Clinical Trial

Official title:

Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03874806
• Other study ID #: HM20014803
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Pain, Chest
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
0.25% ropivacaine administered through a nerve catheter
• Ropivacaine 0.2%-NaCl 0.9% Injectable Solution
0.2% ropivacaine administered through a nerve catheter

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter	28 hours
Primary	Tmax	The time elapsed from initial ropivacaine administration to Cmax	28 hours
Primary	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	4 hours
Primary	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	4 hours