R.E.C.K vs Exparel in Robotic Nephrectomy

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07092566
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nephrectomy / Methods
  • Pain Management
  • Renal Carcinoma

Eligibility Criteria

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

Interventions

  • Ropivacaine HCL — DRUG
    123 mg, intramuscular
  • Exparel — DRUG
    100 mL total dose - Intramuscular (IM), intraoperatively
  • Epinephrine — DRUG
    0.25 mg, intramuscular
  • Clonidine HCL — DRUG
    0.04 mg, intramuscular
  • Ketorolac — DRUG
    15 mg, intramuscular

Study Details

The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

Key Dates

Start date
Nov 14, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

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

Arms

  • Active Comparator: Arm A
    Intraoperative R.E.C.K.
  • Experimental: Arm B
    Intraoperative Exparel

Primary Outcome Measure

Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K. [ Time Frame: Day of Surgery to Day 7 Post-Surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Levine CancerCharlotteNorth Carolina28204
Margarita Dzhanumova
[email protected]
980-442-2000
Roy Ornob, MD (PRINCIPAL_INVESTIGATOR)

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