NCT07092566 R.E.C.K vs Exparel in Robotic Nephrectomy
| NCT ID | NCT07092566 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Renal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 170 participants in total. It began in 2025-11-14 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Roy Ornob, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT07092566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07092566 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 170 participants.
Is NCT07092566 currently recruiting?
Yes, NCT07092566 is actively recruiting participants. Visit ClinicalTrials.gov or contact Wake Forest University Health Sciences to inquire about joining.
Where is the NCT07092566 trial being conducted?
This trial is being conducted at Charlotte, United States.
Who is sponsoring the NCT07092566 clinical trial?
NCT07092566 is sponsored by Wake Forest University Health Sciences. The principal investigator is Roy Ornob, MD at Wake Forest University Health Sciences. The trial plans to enroll 170 participants.