Clinical trial NCT03961048: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Pain, Chest
Keywords: Erector Spinae
Cardiac Surgery
Regional Anesthesia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Median Effective Dose
timeFrame: 6.5 hours
Secondary outcomes:
measure: Change in pain rating
timeFrame: From just before to 30 minutes after a bolus is administered
measure: Change in heart rate
timeFrame: From just before to 30 minutes after a bolus is administered
measure: Blood pressure
timeFrame: From just before to 30 minutes after a bolus is administered
measure: Change in percent oxygen saturation of hemoglobin
timeFrame: From just before to 30 minutes after a bolus is administered
measure: Changes in electrocardiogram tracing
timeFrame: From just before a bolus is administered to 6.5 hours
measure: Dermatomal coverage
timeFrame: From just before to 30 minutes after a bolus is administered
measure: Opioid consumption
timeFrame: 6.5 hours
measure: Non-narcotic pain medication consumption
timeFrame: 6.5 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bryant Tran, MD
role: PRINCIPAL_INVESTIGATOR
References: