Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery
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ClinicalTrials.gov Identifier: NCT06050551 |
Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Post Operative Pain, Acute Post-Op Complication Opioid Use, Unspecified ERAS Uniportal Video-Assisted Thoracic Surgery (VATS) | Procedure: uniportal VATS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Actual Study Start Date : | March 8, 2023 |
Estimated Primary Completion Date : | November 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: 14-Fr pigtail catheter after uniportal VATS
smaller catheter used after uniportal VATS
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Procedure: uniportal VATS
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20-Fr chest tube after uniportal VATS
routine management after uniportal VATS
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Procedure: uniportal VATS
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- The VAS (Visual Analogue Scale) [ Time Frame: after operation 0, 2, 4, 8, 24, 48 hours ]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.
- morphine usage [ Time Frame: in the first 24 hours after operation, ]cumulative intravenous morphine consumption
- if there is any episodes of nausea or vomiting episodes that needs mediaction [ Time Frame: after operation 0, 2, 4, 8, 24, 48 hours ]related to anesthesia or analgesia.
- pleural drainage from chest tube or pigtail, which was recorded by nurse. [ Time Frame: after operation 24, 48, 72, 96 hours ]after uniportal VATS (Video-Assisted Thoracic Surgery)
- if there is any timepoint for need of conversion to tube thoracotomy from pigtail catheter [ Time Frame: after operation 24, 48, 72, 96 hours ]related to post-operative complications, such as massive pleural effusion, pneumothorax, unstable vital signs or respiratory failure
- post-operative care after uniportal VATS (Video-Assisted Thoracic Surgery) [ Time Frame: after operation 24, 48, 72, 96 hours ]the timing of chest tube removal and length of hospital stays
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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- eighty consecutive adult patients undergoing elective uniportal VATS lobectomy
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050551
Contact: shuoying dai | 0928257828 | hsnu_10@yahoo.com.tw |
Taiwan | |
Yuan's General Hospital | Recruiting |
Kaohsiung, Taiwan, 806 | |
Contact: shuoying dai 0928257828 hsnu_10@yahoo.com.tw |
Responsible Party: | Dai, Shuoying, medical doctor, attending physician, National Cheng-Kung University Hospital |
ClinicalTrials.gov Identifier: | NCT06050551 |
Other Study ID Numbers: |
20221108B |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
post-operative analgesia ERAS (Enhanced Recovery After Surgery) pigtail chest tube |
Pain, Postoperative Acute Pain Postoperative Complications |
Pathologic Processes Pain Neurologic Manifestations |