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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ropivacaine HCL
Drug123 mg, intramuscular
Exparel
Drug100 mL total dose - Intramuscular (IM), intraoperatively
Epinephrine
Drug0.25 mg, intramuscular
Clonidine HCL
Drug0.04 mg, intramuscular
Ketorolac
Drug15 mg, intramuscular
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Arm AActive comparator 4 interventions
Group B: Arm BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day of Surgery to Day 7 Post-SurgerySecondary outcomes
1
Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K.
Assess modeled daily pain scores using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. The NRS is a scale to evaluate pain in 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?"
Time frame
Day of Surgery to Day 7 Post-Surgery2
Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.
Total opioid consumption will be calculated for each participant as the sum of all administered opioid doses from Postoperative Day 0 through Day 7. All opioid doses will be converted to morphine equivalent dose (MED) using standard conversion factors. The total MED will be compared between treatment arms .
Time frame
Day of Surgery to Day 7 Post-Surgery3
Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.
Assess modeled daily postsurgical opioid consumption using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. Daily totals in morphine equivalent dose will be calculated for each participant.
Time frame
Day of Surgery to Day 7 Post-Surgery4
Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K.
Total milligrams consumed for each for ibuprofen, acetaminophen, and naproxen will be calculated for each participant as the sum of the total milligrams consumed from Post Operative Day 0 trough Post Operative Day 7 and compared between arms. The total milligrams consumed will be compared between treatment arms.
Time frame
Day of Surgery to Day 7 Post-SurgeryOther outcomes
1
Proportion of participants experiencing any study -drug related adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K.
A binary variable indicating experience of at least one AE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms.
Time frame
Day of Surgery to Day 30 Post-Surgery2
Proportion of participants experiencing any study -drug related Grade 3+ adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K.
A binary variable indicating experience of at least one Grade 3+ AE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms.
Time frame
Day of Surgery to Day 30 Post-Surgery3
Proportion of participants experiencing any serious adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K.
A binary variable indicating experience of at least one SAE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms.
Time frame
Day of Surgery to Day 30 Post-Surgery4
Proportion of participants experiencing any surgical complications within 14 days of surgery for participants receiving Exparel vs. R.E.C.K.
A binary variable indicating experience of at least one surgical complication occurring within 14 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms.
Time frame
Day of Surgery to Day 14 Post-SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Source ClinicalTrials.gov