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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03961048
• Other study ID #: HM20014242
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 23, 2019
• Est. completion date: September 2020

Study information

• Verified date: January 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chest Pain
• Pain, Chest
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6.5 hours
Secondary	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	From just before to 30 minutes after a bolus is administered
Secondary	Change in heart rate	Heart rate measured using a heart rate monitor	From just before to 30 minutes after a bolus is administered
Secondary	Blood pressure	Blood pressure measured using a blood pressure monitor	From just before to 30 minutes after a bolus is administered
Secondary	Change in percent oxygen saturation of hemoglobin	Pulse oximetry reading from a monitor	From just before to 30 minutes after a bolus is administered
Secondary	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.	From just before a bolus is administered to 6.5 hours
Secondary	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	From just before to 30 minutes after a bolus is administered
Secondary	Opioid consumption	Total opioid medication consumption during the study period	6.5 hours
Secondary	Non-narcotic pain medication consumption	Total non-narcotic pain medicine consumption during the study period	6.5 hours