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

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

Recruiting
18-64 years
All
Phase N/A

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Overview

Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. In the absence of effective pain management, acute pain may progress to chronic pain. Although opioids provide reliable analgesic effects, their associated adverse reactions limit their application following minimally invasive procedures. Regional analgesia serves as the cornerstone of multimodal analgesia, and ultrasound-guided nerve block techniques have become increasingly refined. Ultrasound-guided transversus abdominis plane block(TAPB) generally fulfills intraoperative and postoperative analgesic requirements for laparoscopic surgeries by inhibiting the transmission of nociceptive stimuli in the targeted region, thereby aiding in the prevention of central sensitization. Conventional TAPB utilize local anesthetics, which demonstrate excellent efficacy in alleviating incisional pain. However, the short duration of analgesia provided by conventional local anesthetics significantly compromises their clinical utility.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.

Eligibility

Inclusion Criteria:

  1. Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy 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.

Study details
    Laparoscopic Surgery
    Liposomal Bupivacaine
    Transversus Abdominis Plane Block

NCT07458282

Beijing Tiantan Hospital

13 May 2026

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