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NCT Number: NCT07458256

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

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.

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Key information

Conditions

Laparoscopic Surgery Liposomal Bupivacaine Local Infiltration

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

+86 13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

    Time frame: The postoperative period 48 hours.

Secondary outcomes

  1. Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

    Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 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.

  2. Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively

    Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 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.

  3. Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

    Time frame: Postoperative day 7, month 1, and month 3.

    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.

  4. Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively

    Time frame: Postoperative day 7, month 1, and month 3.

    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.

  5. Time to request of first analgesia

    Time frame: Within 48 hours postoperatively.

  6. Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses

    Time frame: Postoperative Hours 4, 8, 24, and 48.

  7. Duration days of Oral Oxycodone and Acetaminophen Tablets Administration

    Time frame: Within 3 months postoperatively.

  8. Patient Satisfaction Scale，PSS

    Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.

    On a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."

  9. Ramsay Sedation Scale，RSS

    Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.

    The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation.

  10. Quality of Recovery-40，QoR-40

    Time frame: Postoperative hours 24, 48, and 72.

    The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality).

  11. The length of stay in the post-anesthesia care unit（PACU）

    Time frame: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.

    The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward.

  12. Length of Stay (LOS)

    Time frame: Perioperation.

  13. Total hospitalization expenses incurred during the patient's inpatient stay

    Time frame: Perioperation.

  14. Postoperative nausea and vomiting，PONV

    Time frame: Postoperatively within 72 hours.

  15. Total dosage of orally oxycodone and acetaminophen tablets

    Time frame: Within 3 months postoperatively.

  16. Adverse events，AEs

    Time frame: Within 72 hours postoperatively.

    Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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