Renal Carcinoma, Nephrectomy / Methods, Pain Management
Conditions
Keywords
Analgesics, Nephrectomy
Brief summary
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
DRUGRopivacaine HCL
123 mg, intramuscular
DRUGExparel
100 mL total dose - Intramuscular (IM), intraoperatively
DRUGEpinephrine
0.25 mg, intramuscular
DRUGClonidine HCL
0.04 mg, intramuscular
DRUGKetorolac
15 mg, intramuscular
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day of Surgery to Day 7 Post-Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | 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?" |
| Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | 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 . |
| Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | 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. |
| Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | 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. |
| Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Assess modeled daily postsurgical non-opioid consumption using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. Medications informing this analysis include ibuprofen, acetaminophen, and naproxen. Daily totals in milligrams consumed will be calculated for each participant. |
| Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | The proportion of participants who did not receive any opioid medication from Postoperative Day 0 through Day 7. Participants will be classified as opioid-free if their total opioid consumption during this period is zero (0 mg morphine equivalent dose). The proportion will be compared between treatment arms. |
| Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Time to first opioid intake will be defined as the time, in hours, from end of surgery to first opioid medication taken. If participant does not use opioid medication, the time to first opioid intake will be censored at the end of POD7. This will be compared between the arms. |
| Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 30 Post-Surgery | Length of inpatient stay is defined as the total duration, in days (where a full day includes an overnight stay), from the end of surgery until the participant is formally discharged from the hospital. This measure will be used to compare hospitalization duration between treatment arms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoy Ornob, MD
Wake Forest University Health Sciences
Outcome results
None listed