Liposomal bupivacaine TAP block to reduce pain after laparoscopic gynecologic cancer surgery

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery in Gynecologic Oncology:A Multi-Center Randomized Controlled Trial

This trial will test whether a long‑acting liposomal form of bupivacaine given as a transversus abdominis plane (TAP) block reduces postoperative pain for adults having laparoscopic gynecologic oncology surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07458295 on ClinicalTrials.gov

What this trial studies

This interventional, single‑center trial at Beijing Tiantan Hospital compares standard bupivacaine hydrochloride with liposomal bupivacaine plus bupivacaine administered as a TAP block for patients undergoing elective laparoscopic gynecologic oncology procedures under general anesthesia. Participants meeting inclusion criteria (age 18–64, ASA I–III, GCS 15) receive the assigned TAP block at surgery and are followed for postoperative pain and safety outcomes. Key outcomes likely include pain scores, opioid consumption, and adverse events related to the nerve block. The protocol excludes patients with chronic pain syndromes, coagulation dysfunction, certain cardiac conditions, insulin‑treated diabetes, or active gastric bleeding.

Who should consider this trial

Good fit: Adults aged 18–64 having elective laparoscopic gynecologic oncology surgery under general anesthesia with ASA physical status I–III and capacity to consent are the intended candidates.

Not a fit: Patients with chronic pain, coagulation disorders, certain cardiac conduction problems, insulin‑treated diabetes, active gastric bleeding, or ongoing anticoagulant use are excluded and therefore unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide longer‑lasting local pain control after surgery, reduce opioid use, and shorten recovery for eligible patients.

How similar studies have performed: Previous studies of liposomal bupivacaine for regional blocks in abdominal and gynecologic procedures have shown mixed but generally promising results for prolonging analgesia and reducing opioid use.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for elective Laparoscopic Surgery in Gynecologic Oncology under general anesthesia;
2. Ages 18 to 64 years old；
3. American Society of Anesthesiologists (ASA) physical status of I-III；
4. Glasgow Coma Scale (GCS) score of 15；
5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.

Exclusion Criteria:

1. History of chronic pain syndrome of any cause.
2. Patients with heart conduction block (sinus block or atrioventricular block).
3. Patients with unstable coronary artery disease.
4. Patients with gastric ulcer or gastric bleeding.
5. Patients with diabetes and are being treated with insulin.
6. Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
7. Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
8. Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
10. Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
11. Pregnancy or breastfeeding.
12. Extreme body mass index (BMI) (\< 15 or \> 35).
13. Participation in another interventional trial that interferes with the intervention or outcome of this trial.
14. Patients with a history of allergy to local anaesthetics or one of the study drugs.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Laparoscopic Surgery; Gynecologic Oncology Patient; Liposomal Bupivacaine; Transversus Abdominis Plane Block