About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy 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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Bupivacaine hydrochloride
DrugPrior 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
DrugPrior 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.
Treatment groups
Trial outcomes
Primary outcomes
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Secondary outcomes
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 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
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
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
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.
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