Recruiting

Phase 3

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

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07092566

Conditions

Renal Carcinoma

Nephrectomy / Methods

Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ropivacaine HCL

Exparel

Epinephrine

Clonidine HCL

Ketorolac

Study Details

Brief 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.

Conditions

Renal Carcinoma

Nephrectomy / Methods

Pain Management

Study ID

NCT07092566

Start date

Nov 14, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A

Intraoperative R.E.C.K.

experimental: Arm B

Intraoperative Exparel

Interventions

Ropivacaine HCL

123 mg, intramuscular

Exparel

100 mL total dose - Intramuscular (IM), intraoperatively

Epinephrine

0.25 mg, intramuscular

Clonidine HCL

0.04 mg, intramuscular

Ketorolac

15 mg, intramuscular

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 ]

Central Contacts and Locations

Locations

Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Margarita Dzhanumova

980-442-2000 Margarita.Dzhanumova@advocatehealth.org

Principal Investigator:

Roy Ornob, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

Analgesics
Nephrectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-13.