Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06050551
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The VAS (Visual Analogue Scale)', 'timeFrame': 'after operation 0, 2, 4, 8, 24, 48 hours', 'description': 'resting and dynamic VAS (Visual Analogue Scale) while coughing and ambulation, the scale from "0" to "10", depending on the severity of pain. "0" means not painful, and "10" means the most pain in whole life.'}, {'measure': 'morphine usage', 'timeFrame': 'in the first 24 hours after operation,', 'description': 'cumulative intravenous morphine consumption'}, {'measure': 'if there is any episodes of nausea or vomiting episodes that needs mediaction', 'timeFrame': 'after operation 0, 2, 4, 8, 24, 48 hours', 'description': 'related to anesthesia or analgesia.'}], 'secondaryOutcomes': [{'measure': 'pleural drainage from chest tube or pigtail, which was recorded by nurse.', 'timeFrame': 'after operation 24, 48, 72, 96 hours', 'description': 'after uniportal VATS (Video-Assisted Thoracic Surgery)'}, {'measure': 'if there is any timepoint for need of conversion to tube thoracotomy from pigtail catheter', 'timeFrame': 'after operation 24, 48, 72, 96 hours', 'description': 'related to post-operative complications, such as massive pleural effusion, pneumothorax, unstable vital signs or respiratory failure'}, {'measure': 'post-operative care after uniportal VATS (Video-Assisted Thoracic Surgery)', 'timeFrame': 'after operation 24, 48, 72, 96 hours', 'description': 'the timing of chest tube removal and length of hospital stays'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-operative analgesia', 'ERAS (Enhanced Recovery After Surgery)', 'pigtail', 'chest tube'], 'conditions': ['Post Operative Pain, Acute', 'Post-Op Complication', 'Opioid Use, Unspecified', 'ERAS', 'Uniportal Video-Assisted Thoracic Surgery (VATS)']}, 'descriptionModule': {'briefSummary': 'This study aims to figure out how small-bore pigtail catheter or large-bore chest tube for postoperative drainage impact on analgesic efficacy and actually enhance recovery postoperatively.', 'detailedDescription': "Design A randomized controlled trial.\n\nSetting The uniportal VATS has a small linear wound about 3 to 5 cm at only one intercostal space, mostly 4th or 5th. After elective thoracic surgery, the investigators routinely placed either one 14-Fr pigtail catheter or one 20-Fr chest tube for postoperative drainage.\n\nThe patients regularly receive thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation, and are routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need. The investigators check chest X ray on postoperative day one and try to remove the drainage tube soon if well lung expansion and ambulation without adverse events. Then the investigators will discharge this patient six hours later or the next day after drain removal smoothly.\n\nSample size determination and statistical analysis The patient number in one group will be calculated on the basis of significant pain relief and set as 33 patients with the following statistic parameter: α: 0.05 (type I error probability), power 0.8 (probability of correctly rejecting the null hypothesis), δ: 0.5 (difference in population means), σ: 1 (standard deviation of difference). The investigators added 20 % noncompliance rate and forty patients in each group (total eighty patients) will be included in this study.\n\nParticipants The investigators enrolled eighty consecutive adult patients, over 20 years old, undergoing elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc. The exclusion criteria are patient refusal, body mass index \\> 27 kg/m2, American society of anesthesiologists (ASA) grade above 3, contraindication to nerve block, allergy to analgesic agents, regular opioid used for chronic pain prior to this time surgery, anticipating postoperative patient control analgesia (PCA) before operation, surgeon's decision for exclusion during operation, conversion to thoracotomy or multiportal VATS procedure, postoperative intubation, postoperative intensive care unit admission.\n\nInterventions Eighty adult patients, over 20 years old, were allocated randomly in a 1:1 ratio by computer-generated randomization to receive either one 14-Fr pigtail catheter or one 20-Fr chest tube for postoperative pleural drainage.\n\nMeasurement / Result The patient demographics, comorbidities, and thoracic surgical procedure, intra-operative blood loss, operative time, pathological results are reviewed.\n\nThe evaluation and measurement of primary and secondary outcomes are recorded by nurses or assistants at post-anesthetic care unit and ward. The independent samples t test, Chi-square test, Logistic Regression will be used for data analysis.\n\nPrimary outcome The resting and dynamic VAS (Visual Analogue Scale) while coughing and ambulation after operation 0, 2, 4, 8, 24, 48 hours are collected, as well as the postoperative nausea or vomiting episodes related to anesthesia or analgesia.\n\nThe investigators also record the first-time usage of intravenous morphine, cumulative intravenous morphine consumption in the first two postoperative days, and, if need, the additional analgesic agent or rescue analgesia requirement, such as patient controlled analgesia.\n\nSecondary outcome The investigators record the function and daily amount of the pleural drainage, the interpretation of postoperative day one chest X ray, any attempts of additional pleural drain insertion or conversion to tube thoracotomy from pigtail catheter if need. In addition, the timing of chest tube removal, length of hospital stays, and surgical pulmonary complications or morbidity are also noted.\n\nConclusion The investigators will discover if the small-bore pigtail catheter placement would be equally or superiorly effective over analgesia and the following early recovery postoperatively after uniportal VATS, comparing to traditional chest tube. Then the protocol of minimally invasive thoracic operation will be revised and advanced."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- eighty consecutive adult patients undergoing elective uniportal VATS lobectomy\n\nExclusion Criteria:\n\n\\- patient refusal, body mass index \\> 27 kg/m2, American society of anesthesiologists (ASA) grade above 3, contraindication to nerve block, allergy to analgesic agents, regular opioid used for chronic pain prior to this time surgery, anticipating postoperative patient control analgesia (PCA) before operation, surgeon's decision for exclusion during operation, conversion to thoracotomy or multiportal VATS procedure, postoperative intubation, postoperative intensive care unit admission."}, 'identificationModule': {'nctId': 'NCT06050551', 'briefTitle': 'Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Comparison of Postoperative Small-bore Pigtail or Large-bore Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery for Postoperative Analgesia and Enhanced Recovery: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '20221108B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '14-Fr pigtail catheter after uniportal VATS', 'description': 'smaller catheter used after uniportal VATS', 'interventionNames': ['Procedure: uniportal VATS']}, {'type': 'OTHER', 'label': '20-Fr chest tube after uniportal VATS', 'description': 'routine management after uniportal VATS', 'interventionNames': ['Procedure: uniportal VATS']}], 'interventions': [{'name': 'uniportal VATS', 'type': 'PROCEDURE', 'description': "1. elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc.\n\n (exclude the bil. operation, extended wound length over 5 cm, conversion to thoracotomy or multiportal VATS procedure, surgeon's decision for exclusion during operation.)\n2. thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation,\n3. routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.", 'armGroupLabels': ['14-Fr pigtail catheter after uniportal VATS', '20-Fr chest tube after uniportal VATS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '806', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'shuoying dai', 'role': 'CONTACT', 'email': 'hsnu_10@yahoo.com.tw', 'phone': '0928257828'}], 'facility': "Yuan's General Hospital", 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'shuoying dai', 'role': 'CONTACT', 'email': 'hsnu_10@yahoo.com.tw', 'phone': '0928257828'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Yuan's General Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor, attending physician', 'investigatorFullName': 'Dai, Shuoying', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}