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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04117074 | Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery | PHASE3 | COMPLETED | 106 | — | — | Apr 14, 2021 | Mar 17, 2025 | Apr 23, 2025 | 1 | United States |
Pain intensity will be measured using visual analog scale (VAS) pain intensity scores. The VAS scores pain intensity on a scale of 0-10, where 0 is no pain and 10 is the most severe pain.
Total opioid consumption in IV mg morphine equivalents from 0 to 48 hours postoperatively will be compared between the two arms.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Thoracic Epidural Analgesia with bupivicaine | EXPERIMENTAL | Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter \[mL\] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance. |
| Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine | EXPERIMENTAL | Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons. |
| Name | Type | Description |
|---|---|---|
| Liposomal bupivacaine | DRUG | Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure. |
| Thoracic epidural analgesia (bupivacaine) | OTHER | Perioperative bupivacaine based thoracic epidural placed preoperatively. |
Inclusion Criteria: * Individuals ≥ 18 years of age * Planned laparotomy by the gynecologic oncology service at the sponsor institution. Exclusion Criteria: * Individuals who have a contraindication to thoracic epidural analgesia * Individuals with a coagulation disorder * Individuals with an inf...