Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:53 AM
Study NCT ID:
NCT07441902
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', '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': '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': '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': 'Intraoperative Anesthetic Dosage', 'timeFrame': 'During the surgical anesthesia phase.'}, {'measure': 'Patient Satisfaction Scale，PSS', 'timeFrame': 'Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.', 'description': 'Patient Satisfaction Scale(PSS) 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 duration 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': 'Adverse events，AEs', 'timeFrame': 'Within 72 hours postoperatively.', 'description': 'Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.'}, {'measure': 'Total dosage of orally oxycodone and acetaminophen tablets', 'timeFrame': 'Within 3 months postoperatively.'}, {'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 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Video-assisted Thoracoscopic Surgery (VATS)', 'Pain Management', 'Liposomal Bupivacaine', 'Rhomboid Intercostal Block']}, 'referencesModule': {'references': [{'pmid': '38668898', 'type': 'BACKGROUND', 'citation': 'Ciftci B, Alver S, Gungor H, Golboyu BE, Subasi M, Omur B, Gul YG, Ekinci M. The efficacy of rhomboid intercostal block for pain management after video-assisted thoracoscopic surgery: a prospective, randomized-controlled trial. Gen Thorac Cardiovasc Surg. 2024 Dec;72(12):779-785. doi: 10.1007/s11748-024-02036-8. Epub 2024 Apr 26.'}, {'pmid': '37377368', 'type': 'BACKGROUND', 'citation': 'Wang X, Jia X, Li Z, Zhou Q. Rhomboid intercostal block or thoracic paravertebral block for postoperative recovery quality after video-assisted thoracic surgery: A prospective, non-inferiority, randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):652-659. doi: 10.1097/EJA.0000000000001872. Epub 2023 Jun 28.'}, {'pmid': '35296252', 'type': 'BACKGROUND', 'citation': 'Chen R, Su S, Shu H. Efficacy and safety of rhomboid intercostal block for analgesia in breast surgery and thoracoscopic surgery: a meta-analysis. BMC Anesthesiol. 2022 Mar 16;22(1):71. doi: 10.1186/s12871-022-01599-4.'}, {'pmid': '35832798', 'type': 'BACKGROUND', 'citation': 'Zhang JG, Jiang CW, Deng W, Liu F, Wu XP. Comparison of Rhomboid Intercostal Block, Erector Spinae Plane Block, and Serratus Plane Block on Analgesia for Video-Assisted Thoracic Surgery: A Prospective, Randomized, Controlled Trial. Int J Clin Pract. 2022 Jun 23;2022:6924489. doi: 10.1155/2022/6924489. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy. It is reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process.If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge.In recent years, multimodal postoperative analgesia protocols have been increasingly adopted in clinical practice. The Rhomboid intercostal block (RIB), as a novel regional anesthesia technique within the multimodal analgesia framework, has been widely utilized in various thoracic surgical procedures. Liposomal bupivacaine, an innovative long-acting sustained-release amide local anesthetic, provides prolonged analgesia for up to 72 hours. However, its efficacy and safety in video-assisted thoracoscopic surgery (VATS) have not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of ultrasound-guided Rhomboid intercostal block (RIB) utilizing liposomal bupivacaine combined with conventional bupivacaine for postoperative pain management in patients undergoing VATS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;\n* Ages 18 to 64 years old；\n* American Society of Anesthesiologists (ASA) physical status of I-III；\n* Glasgow Coma Scale (GCS) score of 15；\n* 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\n* History of chronic pain syndrome of any cause.\n* Patients with heart conduction block (sinus block or atrioventricular block).\n* Patients with unstable coronary artery disease.\n* Patients with gastric ulcer or gastric bleeding.\n* Patients with diabetes and are being treated with insulin.\n* 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.\n* 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.\n* Patients with renal impairment (serum creatinine \\> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.\n* Patients with a history of diagnosed mental illness or currently taking psychotropic medication.\n* 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.\n* Pregnancy or breastfeeding.\n* Extreme body mass index (BMI) (\\< 15 or \\> 35).\n* Participation in another interventional trial that interferes with the intervention or outcome of this trial.\n* Patients with a history of allergy to local anaesthetics or one of the study drugs.'}, 'identificationModule': {'nctId': 'NCT07441902', 'briefTitle': 'The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Ultrasound-Guided Liposomal Bupivacaine Plus Bupivacaine Rhomboid Intercostal Block for Postoperative Pain Relief in Patients Undergoing Thoracoscopic Surgery:A Multi-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY2025-289-02-2'}}, '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': 'Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of 0.25% bupivacaine will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, 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': 'Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of a mixed solution-comprising 10 mL of liposomal bupivacaine (133 mg) and 10 mL of 0.25% bupivacaine diluted in normal saline-will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, 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'}], 'overallOfficials': [{'name': 'Fang Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, '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'}}}}