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The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
13611326978@163.com
+86 13611326978
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 190
Treatments
Active_comparator: Bupivacaine hydrochloride
Experimental: Liposomal bupivacaine plus bupivacaine
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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