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

NCT07458295 | Recruiting DMC

• 1 other identifier: KY2025-289-02-6
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

  The postoperative period 48 hours.

Secondary Outcomes (17)

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

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

• Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively

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

• Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

  Postoperative day 7, month 1, and month 3.

• Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively

  Postoperative day 7, month 1, and month 3.

• Time to request of first analgesia

  Within 48 hours postoperatively.

Study Arms (2)

Bupivacaine hydrochloride

ACTIVE COMPARATOR

Drug: Bupivacaine hydrochloride

Liposomal bupivacaine plus bupivacaine

EXPERIMENTAL

Drug: Liposomal bupivacaine plus bupivacaine

Interventions

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.

Bupivacaine hydrochloride

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.

Liposomal bupivacaine plus bupivacaine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (3)

• Korkmaz Toker M, Altiparmak B, Uysal AI, Demirbilek SG. The analgesic efficacy of oblique subcostal transversus abdominis plane block after laparoscopic hysterectomy: A randomized, controlled, observer-blinded study. Medicine (Baltimore). 2019 Jan;98(1):e13994. doi: 10.1097/MD.0000000000013994.

  PMID: 30608444 BACKGROUND

• Hutchins J, Vogel RI, Ghebre R, McNally A, Downs LS Jr, Gryzmala E, Geller MA. Ultrasound-guided subcostal transversus abdominis plane infiltration with liposomal bupivacaine for patients undergoing robotic-assisted hysterectomy: a retrospective study. Int J Gynecol Cancer. 2015 Jun;25(5):937-41. doi: 10.1097/IGC.0000000000000429.

  PMID: 25790044 BACKGROUND

• McDonald V, Wang Y, Patel A, Betcher R, Fontenot AC, Scoggin S, Black D. Laparoscopic guided liposomal bupivacaine injection compared to transversus abdominus plane block for postoperative pain after robotic gynecologic oncology surgery. Gynecol Oncol. 2022 Sep;166(3):432-437. doi: 10.1016/j.ygyno.2022.06.006. Epub 2022 Jul 9.

  PMID: 35817618 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Ambulatory Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)