The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery

NCT07458256 | Recruiting DMC

• 1 other identifier: KY2025-289-02-4
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Surgery; Liposomal Bupivacaine; Local Infiltration

Outcome Measures

Primary Outcomes (1)

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

  The postoperative period 48 hours.

Secondary Outcomes (16)

• 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

The 40 mL 0.25% Bupivacaine hydrochloride (100 mg, normal saline dilution) for the Bupivacaine hydrochloride group.Local infiltration will be performed by the surgeon before closure. A total of 30mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Bupivacaine hydrochloride

Liposomal bupivacaine plus bupivacaine DRUG

The 20 mL (266 mg) of liposomal bupivacaine will be mixed with a volume of 20 mL 0.25% Bupivacaine hydrochloride (50 mg, normal saline dilution) for the Liposomal Bupivacaine plus Bupivacaine hydrochloride group.Local infiltration will be performed by the surgeon before closure. A total of 30mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, 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 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.

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)

• Keller DS, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Pilot study of a novel pain management strategy: evaluating the impact on patient outcomes. Surg Endosc. 2016 Jun;30(6):2192-8. doi: 10.1007/s00464-015-4459-4. Epub 2015 Aug 15.

  PMID: 26275549 BACKGROUND

• Waddimba AC, Newman P, Shelley JK, McShan EE, Cheung ZO, Gibson JN, Bennett MM, Petrey LB. Pain management after laparoscopic appendectomy: Comparative effectiveness of innovative pre-emptive analgesia using liposomal bupivacaine. Am J Surg. 2022 May;223(5):832-838. doi: 10.1016/j.amjsurg.2021.09.019. Epub 2021 Sep 24.

  PMID: 34610868 BACKGROUND

• Suseela I, Anandan K, Aravind A, Kaniyil S. Comparison of ultrasound-guided bilateral subcostal transversus abdominis plane block and port-site infiltration with bupivacaine in laparoscopic cholecystectomy. Indian J Anaesth. 2018 Jul;62(7):497-501. doi: 10.4103/ija.IJA_55_18.

  PMID: 30078851 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)