RECRUITING

Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain

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Conditions

Pain, PostoperativeOpioid UsePerioperative ComplicationHeart Diseasesplane blocksternotomythoracotomycardiacsurgerypostoperativepainanesthesiaopioidpragmatic trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.

Official Title

Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes

Quick Facts

Study Start:2024-01-11
Study Completion:2025-04-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06077422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (18 years-no upper age limit)
  2. * Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypass graft) at single academic medical center (in and out-patients).
  1. * Are currently on pain medication or pain regimen for chronic pain condition
  2. * Convert to sternotomy (for thoracotomies)
  3. * Require, upon intraoperative discovery and surgeon's decision, the need for an unplanned secondary procedure other than the originally scheduled index operation
  4. * Undergo emergent surgery
  5. * Are non-English speaking (The majority of the PI's patient population speak English. As a pilot study the investigators cannot afford to enroll non-English speaking subjects due to time, personnel, and financial constraints.)
  6. * Mechanical circulatory support (MCS)
  7. * Vasoactive medications
  8. * Intubated
  9. * Active infection
  10. * Patients otherwise deemed ineligible for ESP block by the investigators due to safety concerns.

Contacts and Locations

Study Contact

Leonard Y Lee, MD
CONTACT
732-235-9220
leele@rwjms.rutgers.edu
Russell J Pepe, MD
CONTACT
rpepe@rwjms.rutgers.edu

Principal Investigator

Leonard Y Lee, MD
PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School, Dept of Surgery

Study Locations (Sites)

Rutgers RWJMS
New Brunswick, New Jersey, 08903
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Leonard Y Lee, MD, PRINCIPAL_INVESTIGATOR, Rutgers Robert Wood Johnson Medical School, Dept of Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2025-04-05

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2025-04-05

Terms related to this study

Keywords Provided by Researchers

  • plane block
  • sternotomy
  • thoracotomy
  • cardiac
  • surgery
  • postoperative
  • pain
  • anesthesia
  • opioid
  • pragmatic trial

Additional Relevant MeSH Terms

  • Pain, Postoperative
  • Opioid Use
  • Perioperative Complication
  • Heart Diseases