The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscop… (NCT07458256) | Clinical Trial Compass
RecruitingNot Applicable
The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery
China190 participantsStarted 2026-03-10
Plain-language summary
Compared with traditional laparotomy, laparoscopic surgery offers advantages including minimal invasiveness, accelerated patient recovery, and reduced hospital stay. Although postoperative incision pain is generally less severe than that following laparotomy, it remains a notable clinical issue that impedes patient recovery. The majority of patients report incisional discomfort, with approximately 30% to 50% requiring oral analgesics to alleviate pain symptoms. Within the first two days after laparoscopic procedures, most patients experience varying degrees of incisional pain, with peak intensity typically occurring within hours after surgery and gradually subsiding over two to three days. Studies indicate that local infiltration anesthesia at the surgical site significantly ameliorates postoperative incision pain, enhances analgesic efficacy, and shortens recovery time in patients undergoing laparoscopic surgery.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours. Some researchers have reported the analgesic effects of LB VS traditional local anesthetics infiltration, but the current research results are highly heterogeneous. More prospective studies are needed to evaluate whether LB infiltration is superior to the traditional local anesthetics for the management of postoperative pain. The investigators designed this study to compare the analgesic effect of using LB plus bupivacaine for local infiltration with bupivacaine along for patients after laparoscopic surgery.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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；
✓. 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.
What they're measuring
1
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
✕. 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.