Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2026-03-17
110
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating the use of liposomal bupivacaine combined with bupivacaine for managing postoperative pain in patients undergoing laparoscopic surgery for gynecologic oncology. Laparoscopic surgery is minimally invasive and allows for faster recovery and shorter hospital stays. However, the procedure can cause diaphragm elevation and increased abdominal pressure, leading to systemic inflammation and postoperative pain. This study aims to assess the safety and effectiveness of this analgesic approach compared to standard treatment. The study compares two groups: one receiving a bilateral transversus abdominis plane block (TAPB) with bupivacaine hydrochloride, and the other receiving TAPB with a mixture of liposomal bupivacaine and bupivacaine. Both procedures use ultrasound guidance before surgery. Postoperatively, patients use a patient-controlled analgesia pump with sufentanil and ondansetron and may take oral oxycodone-acetaminophen or intravenous morphine if needed. The study uses a randomized, quadruple-masked design. Participants will be monitored for pain levels at rest and during movement at intervals up to three months after surgery using the numeric rating scale. Researchers will track opioid use, time to first analgesia request, sedation, patient satisfaction, recovery quality, hospital stay length, complications, and adverse events. The study starts in March 2026 and ends in June 2027, with detailed postoperative and follow-up assessments to evaluate outcomes and safety.
CONDITIONS
The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery in Gynecologic Oncology
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours postoperatively
Participants undergo laparoscopic surgery with a transverse abdominis plane block (TAPB) using either liposomal bupivacaine plus bupivacaine or bupivacaine hydrochloride administered prior to surgical incision. Postoperative pain is managed with a patient-controlled analgesia pump and, if needed, additional oral or intravenous analgesics.
1 surgical visit and in-hospital monitoring for 48 hours postoperatively
Duration - Up to 3 months postoperatively
Participants are monitored for pain levels, recovery quality, adverse events, and medication use up to 3 months after surgery.
Visits at 2 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month, and 3 months postoperatively
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
F
Fang Luo
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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