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

NCT03961048 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: HM20014242
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Pain, Chest

Keywords

Erector Spinae; Cardiac Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in pain rating

  From just before to 30 minutes after a bolus is administered

• Change in heart rate

  From just before to 30 minutes after a bolus is administered

• Blood pressure

  From just before to 30 minutes after a bolus is administered

• Change in percent oxygen saturation of hemoglobin

  From just before to 30 minutes after a bolus is administered

• Changes in electrocardiogram tracing

  From just before a bolus is administered to 6.5 hours

Study Arms (2)

Bilateral catheters

EXPERIMENTAL

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

Single catheter

EXPERIMENTAL

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

Interventions

Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally DRUG

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.

Bilateral catheters

Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally DRUG

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.

Single catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Chest Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bryant Tran, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: July 23, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)