Last updated: January 24, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting
Phase
2/3
Condition
Drug Use
Treatment
Bupivacaine Hydrochloride
bupivacaine liposome injectable suspension
Clinical Study ID
NCT06077422
Pro2022001580
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults (18 years-no upper age limit)
- Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypassgraft) at single academic medical center (in and out-patients).
Exclusion
Exclusion Criteria: Patients will be excluded if they:
- Are currently on pain medication or pain regimen for chronic pain condition
- Convert to sternotomy (for thoracotomies)
- Require, upon intraoperative discovery and surgeon's decision, the need for anunplanned secondary procedure other than the originally scheduled index operation
- Undergo emergent surgery
- 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 speakingsubjects due to time, personnel, and financial constraints.)
- Mechanical circulatory support (MCS)
- Vasoactive medications
- Intubated
- Active infection
- Patients otherwise deemed ineligible for ESP block by the investigators due to safetyconcerns.
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Bupivacaine Hydrochloride
Phase: 2/3
Study Start date:
January 11, 2024
Estimated Completion Date:
April 05, 2025
Study Description
Connect with a study center
Rutgers RWJMS
New Brunswick, New Jersey 08903
United StatesActive - Recruiting


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