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

RecruitingPhase 3

Sponsor: Wake Forest University Health Sciences

Conditions: Renal Carcinoma, Nephrectomy / Methods, Pain Management

Interventions: Ropivacaine HCL, Exparel, Epinephrine, Clonidine HCL, Ketorolac

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Charlotte, North Carolina, United States