R.E.C.K vs Exparel in Robotic Nephrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine HCL, Exparel, Epinephrine, Clonidine HCL.
- Who it may be relevant to
- Registry conditions: Renal Carcinoma, Nephrectomy / Methods, Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial
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.
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.
Interventions
- 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
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 7 Post-Surgery]
- Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K. [Time frame: Day of Surgery to Day 30 Post-Surgery]
Eligibility criteria
Inclusion criteria
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent.
- Planned robotic partial or radical nephrectomy
Exclusion criteria
- Determined not to be a candidate to receive R.E.C.K or Exparel per the enrolling investigator
- Known pregnancy
- Chronic opioid use within 30 days (as per patient report) prior to randomization (defined as ≥ 30 MME/day)
- 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.
- Known allergy to R.E.C.K. and/or Exparel
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Levine Cancer — Charlotte
Identifiers
NCT: NCT07092566 · IRB00133736 · ONC-GU-2404