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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-14

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

NCT03474510

Pain, Postoperative Shoulder Osteoarthritis

WITHDRAWN PHASE4

"The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors"

NCT05355597

Musculoskeletal Diseases Soft Tissue Mass

TERMINATED PHASE2

Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores

NCT03149783

Pain, Postoperative Delirium Anesthesia, Local

UNKNOWN PHASE2

Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

NCT04702685

Pain, Postoperative

UNKNOWN PHASE3

Use of Perioperative Pain Blocks In Urological Surgery

NCT04426500

Pain, Postoperative Nerve Block Robotic Surgical Procedures

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Carcinoma Nephrectomy / Methods Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Intraoperative R.E.C.K.

Group Type ACTIVE_COMPARATOR

Ropivacaine HCL

Intervention Type DRUG

123 mg, intramuscular

Epinephrine

Intervention Type DRUG

0.25 mg, intramuscular

Clonidine HCL

Intervention Type DRUG

0.04 mg, intramuscular

Ketorolac

Intervention Type DRUG

15 mg, intramuscular

Arm B

Intraoperative Exparel

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

100 mL total dose - Intramuscular (IM), intraoperatively

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine HCL

123 mg, intramuscular

Intervention Type DRUG

Exparel

100 mL total dose - Intramuscular (IM), intraoperatively

Intervention Type DRUG

Epinephrine

0.25 mg, intramuscular

Intervention Type DRUG

Clonidine HCL

0.04 mg, intramuscular

Intervention Type DRUG

Ketorolac

15 mg, intramuscular

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

bupivacaine liposome injectable suspension

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No