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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06077422
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bupivacaine liposome injectable suspension — DRUG
    Bupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.
  • Bupivacaine Hydrochloride — DRUG
    Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Feb 2026
Primary completion
Jan 11, 2027
Completion
Apr 5, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exparel
    The experimental medication (Exparel) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).
  • Active Comparator: Marcaine
    The active comparator medication (Marcaine) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).

Primary Outcome Measure

Postoperative opioid consumption [ Time Frame: Postoperative days 0 through 5 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers RWJMSNew BrunswickNew Jersey08903-

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By condition
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By research site
Rutgers RWJMS· New Brunswick, NJ

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