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

Last updated: January 16, 2026
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Urothelial Tract Cancer

Renal Cell Cancer

Urologic Cancer

Treatment

Ropivacaine HCL

ropivacaine + epineprine + clonidine + ketoralac

Epinephrine

Clinical Study ID

NCT07092566
IRB00133736
ONC-GU-2404
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to understand and willingness to sign an IRB-approved informed consent

  2. Age ≥ 18 years at the time of consent.

  3. Planned robotic partial or radical nephrectomy

Exclusion

Exclusion Criteria:

  1. Determined not to be a candidate to receive R.E.C.K or Exparel per the enrollinginvestigator

  2. Known pregnancy

  3. Chronic opioid use within 30 days (as per patient report) prior to randomization (defined as ≥ 30 MME/day)

  4. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements as determined by the investigator.

  5. Known allergy to R.E.C.K. and/or Exparel

Study Design

Total Participants: 170
Treatment Group(s): 6
Primary Treatment: Ropivacaine HCL
Phase: 3
Study Start date:
November 14, 2025
Estimated Completion Date:
October 31, 2027

Study Description

Intra-op opioid administration will be collected and recorded for each participant via EMR review. While in the post anesthesia care unit and the remainder of the inpatient stay, the following will be assessed and captured: pain score via Numerical Rating Score (NRS) captured per standard of care, oral and IV opioid intake, and length of inpatient stay.

After discharge, the participants will be asked to record and timestamp the following in a provided take-home paper diary: pain via NRS in response to the prompt "How much pain are you experiencing right now?" and self-administered medications and dose (ibuprofen, acetaminophen, naproxen, and opioids) throughout the day.

Treatment will be administered intraoperatively.

Connect with a study center

  • Levine Cancer

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Levine Cancer

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

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