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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm A 		Intraoperative R.E.C.K.
  • Drug: Ropivacaine HCL
    123 mg, intramuscular
  • Drug: Epinephrine
    0.25 mg, intramuscular
  • Drug: Clonidine HCL
    0.04 mg, intramuscular
  • Drug: Ketorolac
    15 mg, intramuscular
Experimental
Arm B 		Intraoperative Exparel
  • Drug: Exparel
    100 mL total dose - Intramuscular (IM), intraoperatively
    Other names:
    • bupivacaine liposome injectable suspension

Recruiting Locations

Levine Cancer
Charlotte, North Carolina 28204
Contact:
Margarita Dzhanumova
980-442-2000
Margarita.Dzhanumova@advocatehealth.org

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.