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

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 4

Conditions: Pain, Chest; Pain, Postoperative

Treatments: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally; Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally

Study type: Interventional

Funder types: Other

Identifiers

NCT03961048

HM20014242

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Bilateral catheters

Experimental group

Description:

patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)

Treatment:

Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally

Single catheter

Experimental group

Description:

patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)

Treatment:

Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally