Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters

This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Pain, Chest
• Intervention / Treatment: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally; Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally

Detailed Description

The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively

Exclusion Criteria:

• BMI >40
• infection at the proposed catheter site
• ongoing sepsis/bacteremia
• patient unable to sit up for the procedure
• patients requiring significant vasopressor support (>1 vasopressor)
• patient refusal
• less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral catheters; patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)	Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally; Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
Experimental: Single catheter; patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)	Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally; Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Effective Dose	Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)	6.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain rating	Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be	From just before to 30 minutes after a bolus is administered
Change in heart rate	Heart rate measured using a heart rate monitor	From just before to 30 minutes after a bolus is administered
Blood pressure	Blood pressure measured using a blood pressure monitor	From just before to 30 minutes after a bolus is administered
Change in percent oxygen saturation of hemoglobin	Pulse oximetry reading from a monitor	From just before to 30 minutes after a bolus is administered
Changes in electrocardiogram tracing	Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.	From just before a bolus is administered to 6.5 hours
Dermatomal coverage	The area of numbness experienced in the chest wall as measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders	From just before to 30 minutes after a bolus is administered
Opioid consumption	Total opioid medication consumption during the study period	6.5 hours
Non-narcotic pain medication consumption	Total non-narcotic pain medicine consumption during the study period	6.5 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Bryant Tran, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Regional Anesthesia; Erector Spinae
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chest Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: HM20014242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No