R.E.C.K versus Exparel for pain control during robotic kidney removal
Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial
This will test whether intraoperative R.E.C.K or Exparel gives better pain control and reduces opioid use in adults having robotic partial or radical nephrectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT07092566 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, randomized phase 3 trial compares intraoperative R.E.C.K (ropivacaine with epinephrine, clonidine, and ketorolac) to Exparel (liposomal bupivacaine) in adults undergoing robotic partial or radical nephrectomy. Investigators will record intraoperative opioid use from the medical record and capture post-anesthesia care unit and inpatient pain scores using the Numerical Rating Scale along with oral and IV opioid and over-the-counter analgesic intake and length of stay. After discharge, participants will log time-stamped pain scores and self-administered analgesics in a provided take-home diary. The goal is to determine whether any improvements with Exparel justify its higher cost compared with the R.E.C.K cocktail.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for robotic partial or radical nephrectomy who can consent and are not chronic opioid users are ideal candidates.
Not a fit: Patients who are pregnant, have known allergies to the study drugs, are chronic opioid users, or are deemed unsuitable by the investigator are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could lead to better post-operative pain control or reduced opioid consumption and potentially shorter hospital stays for patients undergoing robotic nephrectomy.
How similar studies have performed: Other studies of liposomal bupivacaine and multimodal local anesthetic cocktails have shown mixed results, so a direct randomized comparison in robotic nephrectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlotte, North Carolina
- Levine Cancer — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Roy Ornob, MD — Wake Forest University Health Sciences
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.