Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Primary Purpose
Pain, Postoperative, Pain, Chest
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally
Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Erector Spinae, Cardiac Surgery, Regional Anesthesia
Eligibility Criteria
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)
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bilateral catheters
Single catheter
Arm Description
patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Change in heart rate
Heart rate measured using a heart rate monitor
Blood pressure
Blood pressure measured using a blood pressure monitor
Change in percent oxygen saturation of hemoglobin
Pulse oximetry reading from a monitor
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.
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
Opioid consumption
Total opioid medication consumption during the study period
Non-narcotic pain medication consumption
Total non-narcotic pain medicine consumption during the study period
Full Information
NCT ID
NCT03961048
First Posted
May 21, 2019
Last Updated
January 22, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03961048
Brief Title
Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Official Title
Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Change in hospital protocol
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Chest
Keywords
Erector Spinae, Cardiac Surgery, Regional Anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral catheters
Arm Type
Experimental
Arm Description
patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
Arm Title
Single catheter
Arm Type
Experimental
Arm Description
patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median Effective Dose
Description
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)
Time Frame
6.5 hours
Secondary Outcome Measure Information:
Title
Change in pain rating
Description
Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be
Time Frame
From just before to 30 minutes after a bolus is administered
Title
Change in heart rate
Description
Heart rate measured using a heart rate monitor
Time Frame
From just before to 30 minutes after a bolus is administered
Title
Blood pressure
Description
Blood pressure measured using a blood pressure monitor
Time Frame
From just before to 30 minutes after a bolus is administered
Title
Change in percent oxygen saturation of hemoglobin
Description
Pulse oximetry reading from a monitor
Time Frame
From just before to 30 minutes after a bolus is administered
Title
Changes in electrocardiogram tracing
Description
Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.
Time Frame
From just before a bolus is administered to 6.5 hours
Title
Dermatomal coverage
Description
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
Time Frame
From just before to 30 minutes after a bolus is administered
Title
Opioid consumption
Description
Total opioid medication consumption during the study period
Time Frame
6.5 hours
Title
Non-narcotic pain medication consumption
Description
Total non-narcotic pain medicine consumption during the study period
Time Frame
6.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryant Tran, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
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