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

Phase 3RecruitingNCT07092566

Wake Forest University Health Sciences170 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Renal Carcinoma

Interventions

Ropivacaine HCLDRUG

123 mg, intramuscular

ExparelDRUG

100 mL total dose - Intramuscular (IM), intraoperatively

EpinephrineDRUG

0.25 mg, intramuscular

Clonidine HCLDRUG

0.04 mg, intramuscular

KetorolacDRUG

15 mg, intramuscular

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.