Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07092566 | R.E.C.K vs Exparel in Robotic Nephrectomy | PHASE3 | RECRUITING | 170 | — | — | Nov 14, 2025 | Oct 1, 2027 | Jan 20, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Intraoperative R.E.C.K. |
| Arm B | EXPERIMENTAL | Intraoperative Exparel |
| Name | Type | Description |
|---|---|---|
| Ropivacaine HCL | DRUG | 123 mg, intramuscular |
| Exparel | DRUG | 100 mL total dose - Intramuscular (IM), intraoperatively |
| Epinephrine | DRUG | 0.25 mg, intramuscular |
| Clonidine HCL | DRUG | 0.04 mg, intramuscular |
| Ketorolac | DRUG | 15 mg, intramuscular |
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...