NCT07092566

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Carcinoma
• Nephrectomy / Methods
• Pain Management

Interventions

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

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-07-30
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study