Renal CarcinomaPhase 3NCT07092566
R.E.C.K vs Exparel in Robotic Nephrectomy
A Phase 3 study testing Ropivacaine HCL, Exparel and Epinephrine in people with Renal Carcinoma and Nephrectomy / Methods, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Carcinoma, Nephrectomy / Methods, Pain Management
- What is being tested?
- Ropivacaine HCL, Exparel and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Known allergy to R.E.C.K. and/or Exparel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer
Charlotte, North Carolina, 28204
Margarita Dzhanumova, 980-442-2000, Margarita.Dzhanumova@advocatehealth.org
Roy Ornob, MD
About this study
Official title: Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective 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.
Read the 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.
- Conditions
- Renal Carcinoma, Nephrectomy / Methods, Pain Management
- Being tested
- Ropivacaine HCL, Exparel, Epinephrine, Clonidine HCL, Ketorolac
- Keywords
- Analgesics, Nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine HCLDrug
123 mg, intramuscular
ExparelDrug
Also called bupivacaine liposome injectable suspension
100 mL total dose - Intramuscular (IM), intraoperatively
EpinephrineDrug
0.25 mg, intramuscular
Clonidine HCLDrug
0.04 mg, intramuscular
KetorolacDrug
15 mg, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Intraoperative R.E.C.K. Receives: Drug: Ropivacaine HCL; Drug: Epinephrine; Drug: Clonidine HCL; Drug: Ketorolac |
| Arm B | Experimental | Intraoperative Exparel Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of Surgery to Day 7 Post-Surgery
Secondary outcomes (8)
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?"
Measured: Day of Surgery to Day 7 Post-Surgery
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 .
Measured: Day of Surgery to Day 7 Post-Surgery
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.
Measured: Day of Surgery to Day 7 Post-Surgery
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.
Measured: Day of Surgery to Day 7 Post-Surgery
Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K.
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.
Measured: Day of Surgery to Day 7 Post-Surgery
Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K.
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.
Measured: Day of Surgery to Day 7 Post-Surgery
Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K.
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.
Measured: Day of Surgery to Day 7 Post-Surgery
Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K.
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.
Measured: Day of Surgery to Day 30 Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start14 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Roy Ornob, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092566
- Sponsor's protocol ID
- IRB00133736
- Other IDs
- ONC-GU-2404
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT07092566
- Acronym / sponsor ID
- IRB00133736
- Conditions
- Renal Carcinoma, Nephrectomy / Methods, Pain Management
- Keywords
- Analgesics, Nephrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Ropivacaine HCL, Drug: Epinephrine, Drug: Clonidine HCL, Drug: KetorolacIntraoperative R.E.C.K. |
| Arm B | Experimental | Drug: ExparelIntraoperative Exparel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Known allergy to R.E.C.K. and/or Exparel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine HCL123 mg, intramuscular | Drug | Arm A |
| ExparelAlso: bupivacaine liposome injectable suspension100 mL total dose - Intramuscular (IM), intraoperatively | Drug | Arm B |
| Epinephrine0.25 mg, intramuscular | Drug | Arm A |
| Clonidine HCL0.04 mg, intramuscular | Drug | Arm A |
| Ketorolac15 mg, intramuscular | Drug | Arm A |
Primary outcome
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.
Time frame: 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.
8 secondary outcomes
Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 7 Post-Surgery
Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K.
Time frame: Day of Surgery to Day 30 Post-Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roy Ornob, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine HCL, Exparel and Epinephrine in people with Renal Carcinoma and Nephrectomy / Methods, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day of Surgery to Day 7 Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.