Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 4:48 PM
Study NCT ID:
NCT07458256
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively', 'timeFrame': 'The postoperative period 48 hours.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively', 'timeFrame': 'Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.', 'description': '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.'}, {'measure': 'Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively', 'timeFrame': 'Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.', 'description': '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.'}, {'measure': 'Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively', 'timeFrame': 'Postoperative day 7, month 1, and month 3.', 'description': '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.'}, {'measure': 'Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively', 'timeFrame': 'Postoperative day 7, month 1, and month 3.', 'description': '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.'}, {'measure': 'Time to request of first analgesia', 'timeFrame': 'Within 48 hours postoperatively.'}, {'measure': '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', 'timeFrame': 'Postoperative Hours 4, 8, 24, and 48.'}, {'measure': 'Duration days of Oral Oxycodone and Acetaminophen Tablets Administration', 'timeFrame': 'Within 3 months postoperatively.'}, {'measure': 'Patient Satisfaction Scale，PSS', 'timeFrame': 'Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.', 'description': 'On a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."'}, {'measure': 'Ramsay Sedation Scale，RSS', 'timeFrame': 'Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.', 'description': '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.'}, {'measure': 'Quality of Recovery-40，QoR-40', 'timeFrame': 'Postoperative hours 24, 48, and 72.', 'description': '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).'}, {'measure': 'The length of stay in the post-anesthesia care unit（PACU）', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Length of Stay (LOS)', 'timeFrame': 'Perioperation.'}, {'measure': "Total hospitalization expenses incurred during the patient's inpatient stay", 'timeFrame': 'Perioperation.'}, {'measure': 'Postoperative nausea and vomiting，PONV', 'timeFrame': 'Postoperatively within 72 hours.'}, {'measure': 'Total dosage of orally oxycodone and acetaminophen tablets', 'timeFrame': 'Within 3 months postoperatively.'}, {'measure': 'Adverse events，AEs', 'timeFrame': 'Within 72 hours postoperatively.', 'description': 'Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery', 'Liposomal Bupivacaine', 'Local Infiltration']}, 'referencesModule': {'references': [{'pmid': '26275549', 'type': 'BACKGROUND', 'citation': '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': '34610868', 'type': 'BACKGROUND', 'citation': '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': '30078851', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia;\n2. Ages 18 to 64 years old；\n3. American Society of Anesthesiologists (ASA) physical status of I-III；\n4. Glasgow Coma Scale (GCS) score of 15；\n5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.\n\nExclusion Criteria:\n\n1. History of chronic pain syndrome of any cause.\n2. Patients with heart conduction block (sinus block or atrioventricular block).\n3. Patients with unstable coronary artery disease.\n4. Patients with gastric ulcer or gastric bleeding.\n5. Patients with diabetes and are being treated with insulin.\n6. 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.\n7. 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.\n8. Patients with renal impairment (serum creatinine \\> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.\n9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication.\n10. 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.\n11. Pregnancy or breastfeeding.\n12. Extreme body mass index (BMI) (\\< 15 or \\> 35).\n13. Participation in another interventional trial that interferes with the intervention or outcome of this trial.\n14. Patients with a history of allergy to local anaesthetics or one of the study drugs.'}, 'identificationModule': {'nctId': 'NCT07458256', 'briefTitle': 'The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KY2025-289-02-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine hydrochloride', 'interventionNames': ['Drug: Bupivacaine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Liposomal bupivacaine plus bupivacaine', 'interventionNames': ['Drug: Liposomal bupivacaine plus bupivacaine']}], 'interventions': [{'name': 'Bupivacaine hydrochloride', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Bupivacaine hydrochloride']}, {'name': 'Liposomal bupivacaine plus bupivacaine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Liposomal bupivacaine plus bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+86 13611326978'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+86 13611326978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Ambulatory Surgery, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}