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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03961048

Collaborator

(none)

Enrollment

Location

Arms

13.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Pain, Chest	Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 23, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Change in heart rate [From just before to 30 minutes after a bolus is administered]
Heart rate measured using a heart rate monitor
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)