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

Wake Forest University (WFU)

Status and phase: Begins enrollment this month; Phase 3

Conditions: Renal Carcinoma; Pain Management; Nephrectomy / Methods

Treatments: Drug: ropivacaine + epineprine + clonidine + ketoralac; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT07092566

IRB00133736

ONC-GU-2404 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Intraoperative R.E.C.K.

Treatment:

Drug: ropivacaine + epineprine + clonidine + ketoralac

Arm B

Experimental group

Description:

Intraoperative Exparel

Treatment:

Drug: Exparel