R.E.C.K vs Exparel in Robotic Nephrectomy

NCT07092566 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IRB00133736ONC-GU-2404
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Carcinoma; Nephrectomy / Methods; Pain Management

Keywords

Analgesics; Nephrectomy

Outcome Measures

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.

  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.

  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.

  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.

  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.

  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.

  Day of Surgery to Day 7 Post-Surgery

Other Outcomes (6)

• Proportion of participants experiencing any study -drug related adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K.

  Day of Surgery to Day 30 Post-Surgery

• 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.

  Day of Surgery to Day 30 Post-Surgery

• Proportion of participants experiencing any serious adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K.

  Day of Surgery to Day 30 Post-Surgery

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Intraoperative R.E.C.K.

Drug: Ropivacaine HCL; Drug: Epinephrine; Drug: Clonidine HCL; Drug: Ketorolac

Arm B

EXPERIMENTAL

Intraoperative Exparel

Drug: Exparel

Interventions

Ropivacaine HCL DRUG

123 mg, intramuscular

Arm A

Exparel DRUG

100 mL total dose - Intramuscular (IM), intraoperatively

Also known as: bupivacaine liposome injectable suspension

Arm B

Epinephrine DRUG

0.25 mg, intramuscular

Arm A

Clonidine HCL DRUG

0.04 mg, intramuscular

Arm A

Ketorolac DRUG

15 mg, intramuscular

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Agnosia

Interventions

Ropivacaine; Epinephrine; Clonidine; Ketorolac

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Roy Ornob, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)