R.E.C.K vs Exparel in Robotic Nephrectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ropivacaine HCL
- Exparel
- Epinephrine
- Clonidine HCL
- Ketorolac
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Source ClinicalTrials.gov