Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block

NCT03874806 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HM20014803
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are as follows:

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

Conditions

Pain, Postoperative; Pain, Chest

Outcome Measures

Primary Outcomes (4)

• Cmax

  The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter

  28 hours

• Tmax

  The time elapsed from initial ropivacaine administration to Cmax

  28 hours

• 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

• 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

Study Arms (2)

single

EXPERIMENTAL

local anesthetic is delivered as a single bolus

Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

continuous

ACTIVE COMPARATOR

local anesthetic is delivered as a continuous infusion

Drug: Ropivacaine 0.2%-NaCl 0.9% Injectable Solution

Interventions

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution DRUG

0.25% ropivacaine administered through a nerve catheter

single

Ropivacaine 0.2%-NaCl 0.9% Injectable Solution DRUG

0.2% ropivacaine administered through a nerve catheter

continuous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Chest Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bryant Tran, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 14, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)