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

Phase 4

Withdrawn

• Conditions: Pain, Postoperative; Pain, Chest
• Interventions: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally; Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally

• Registration Number: NCT03961048
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-07-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral catheters	Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally	patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
Single catheter	Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally	patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)

Primary Outcome Measures

Name	Time	Method
Median Effective Dose	6.5 hours	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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