Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-04 @ 6:29 PM
Study NCT ID:
NCT03839160
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': 'Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'Adult Pain Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic profile - Heart rate', 'timeFrame': 'At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'Heart rate'}, {'measure': 'Hemodynamic profile - blood pressure', 'timeFrame': 'At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'blood pressure'}, {'measure': 'Hemodynamic profile - SpO2', 'timeFrame': 'At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'SpO2'}, {'measure': 'Opioids-related side effects - nausea', 'timeFrame': 'At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'nausea'}, {'measure': 'Catheter-related profile', 'timeFrame': 'at Day 1, Day2 and Day 3 post-operation', 'description': 'The position of the catheter tip and the level of blockade'}, {'measure': 'Morphine consumption', 'timeFrame': 'At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation', 'description': 'Morphine consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Anesthesia', 'Thoracotomy']}, 'descriptionModule': {'briefSummary': 'Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.', 'detailedDescription': 'Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided serratus anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy.\n\nThis is a prospective study carried out in a tertiary hospital. Patients scheduled for thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of opioids-related side effects and length of hospital stay are documented. The primary objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* BMI 18-28kg/m2\n* Wedge incision and lobectomy\n\nExclusion Criteria:\n\n* Uncontrolled hypertension or chronic conditions\n* History of opioid dependence\n* Allergy to bupivacaine hydrochloride\n* Severe bleeding during operation or post operation\n* Inability to communicate with investigators.'}, 'identificationModule': {'nctId': 'NCT03839160', 'briefTitle': 'The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study', 'orgStudyIdInfo': {'id': 'truncal block SAPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SAPB group. Group S', 'description': 'In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.', 'interventionNames': ['Procedure: Serratus anterior plane block', 'Drug: Intravenous patient-controlled-analgesia morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group. Group C', 'description': 'In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.', 'interventionNames': ['Drug: Intravenous patient-controlled-analgesia morphine']}], 'interventions': [{'name': 'Serratus anterior plane block', 'type': 'PROCEDURE', 'otherNames': ['Serratus plane block'], 'description': 'Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.', 'armGroupLabels': ['SAPB group. Group S']}, {'name': 'Intravenous patient-controlled-analgesia morphine', 'type': 'DRUG', 'otherNames': ['PCIA'], 'description': 'Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.', 'armGroupLabels': ['Control group. Group C', 'SAPB group. Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jing Cang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}