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NCT Number: NCT07458295

The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery in Gynecologic Oncology

Laparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in Gynecologic Oncology. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperLaparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in gynecological procedures. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperative pain. Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, transversus abdominis plane block (TAPB) not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation.Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, TAPB not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation. Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing Laparoscopic Surgery in Gynecologic Oncology.

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Key information

Conditions

Laparoscopic Surgery Gynecologic Oncology Patient Liposomal Bupivacaine Transversus Abdominis Plane Block

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

+86 13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

History of chronic pain syndrome of any cause.
Patients with heart conduction block (sinus block or atrioventricular block).
Patients with unstable coronary artery disease.
Patients with gastric ulcer or gastric bleeding.
Patients with diabetes and are being treated with insulin.
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.
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.
Patients with renal impairment (serum creatinine > 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
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.
Pregnancy or breastfeeding.
Extreme body mass index (BMI) (< 15 or > 35).
Participation in another interventional trial that interferes with the intervention or outcome of this trial.
Patients with a history of allergy to local anaesthetics or one of the study drugs.

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, with 20 mL of 0.25% bupivacaine administered per side. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Liposomal bupivacaine plus bupivacaine

Drug

Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, 20 mL (266 mg) of liposomal bupivacaine will be mixed with 20 mL of 0.25% bupivacaine hydrochloride (50 mg, diluted in normal saline) to prepare a 40 mL solution. A volume of 20 mL will be administered to each side.The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Primary outcomes

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame: The postoperative period 48 hours.

Secondary outcomes

Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively

Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

Time frame: Postoperative day 7, month 1, and month 3.

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively

Time frame: Postoperative day 7, month 1, and month 3.

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Time to request of first analgesia

Time frame: Within 48 hours postoperatively.
Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses

Time frame: Postoperative Hours 4, 8, 24, and 48.
Duration days of Oral Oxycodone and Acetaminophen Tablets Administration

Time frame: Within 3 months postoperatively.
Total dosage of orally oxycodone and acetaminophen tablets

Time frame: Within 3 months postoperatively.
Intraoperative Anesthetic Dosage

Time frame: During the surgical anesthesia phase.
Patient Satisfaction Scale，PSS

Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.

Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."
Ramsay Sedation Scale，RSS

Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.

The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation.
Quality of Recovery-40，QoR-40

Time frame: Postoperative hours 24, 48, and 72.

The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality).
The duration of stay in the post-anesthesia care unit（PACU）

Time frame: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.

The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward.
Length of Stay (LOS)

Time frame: Perioperation.
Total hospitalization expenses incurred during the patient's inpatient stay

Time frame: Perioperation.
Postoperative nausea and vomiting，PONV

Time frame: Postoperatively within 72 hours.
Adverse events，AEs

Time frame: Within 72 hours postoperatively.

Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 9, 2026
Registry last updated: Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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