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RecruitingInterventionalPhase 3

Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial

NCT ID: NCT07092566Sponsor: Wake Forest University Health SciencesLast updated: 2026-01-20

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.

Detailed 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.

Arms & interventions

  • DrugRopivacaine HCL

    123 mg, intramuscular

  • DrugExparel

    100 mL total dose - Intramuscular (IM), intraoperatively

  • DrugEpinephrine

    0.25 mg, intramuscular

  • DrugClonidine HCL

    0.04 mg, intramuscular

  • DrugKetorolac

    15 mg, intramuscular

Outcome measures

Primary

  • 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.

    Assess pain intensity (evaluated by NRS) after surgery on the as response to the prompt: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?" The AUC will be derived for each participant from self-reported pain scores and will be summarized by treatment group. Generalized linear models with main effect of treatment will be estimated to test for significant differences in AUC between the arms.

    Time frame: Day of Surgery to Day 7 Post-Surgery

Secondary

  • Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 7 Post-Surgery

  • Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K.

    Time frame: Day of Surgery to Day 30 Post-Surgery

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 Criteria: 1. Determined not to be a candidate to receive R.E.C.K or Exparel per the enrolling investigator 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 active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator. 5. Known allergy to R.E.C.K. and/or Exparel

Study locations (1)

Levine Cancer

Charlotte, North Carolina, 28204

Recruiting
Margarita Dzhanumova · Contact
980-442-2000Margarita.Dzhanumova@advocatehealth.org
Roy Ornob, MD · Principal Investigator