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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Sponsor:

Collaborator:

Yuan's General Hospital

Information provided by (Responsible Party):

Dai, Shuoying, National Cheng-Kung University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Post Operative Pain, Acute Post-Op Complication Opioid Use, Unspecified ERAS Uniportal Video-Assisted Thoracic Surgery (VATS)	Procedure: uniportal VATS	Not Applicable

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Detailed Description:

Design A randomized controlled trial.

Setting 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.

The 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.

Sample 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.

Participants 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.

Interventions 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.

Measurement / Result The patient demographics, comorbidities, and thoracic surgical procedure, intra-operative blood loss, operative time, pathological results are reviewed.

The 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.

Primary 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.

The 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.

Secondary 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.

Conclusion 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.

Study Design

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 14-Fr pigtail catheter after uniportal VATS smaller catheter used after uniportal VATS	Procedure: uniportal VATS elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc. (exclude the bil. operation, extended wound length over 5 cm, conversion to thoracotomy or multiportal VATS procedure, surgeon's decision for exclusion during operation.) thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation, routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.
20-Fr chest tube after uniportal VATS routine management after uniportal VATS	Procedure: uniportal VATS elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc. (exclude the bil. operation, extended wound length over 5 cm, conversion to thoracotomy or multiportal VATS procedure, surgeon's decision for exclusion during operation.) thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation, routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.

Arm

Intervention/treatment

Experimental: 14-Fr pigtail catheter after uniportal VATS

smaller catheter used after uniportal VATS

Procedure: uniportal VATS

elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc.

(exclude the bil. operation, extended wound length over 5 cm, conversion to thoracotomy or multiportal VATS procedure, surgeon's decision for exclusion during operation.)
thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation,
routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.

20-Fr chest tube after uniportal VATS

routine management after uniportal VATS

Procedure: uniportal VATS

elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc.

(exclude the bil. operation, extended wound length over 5 cm, conversion to thoracotomy or multiportal VATS procedure, surgeon's decision for exclusion during operation.)
thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation,
routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Eligibility Criteria

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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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: shuoying dai	0928257828	hsnu_10@yahoo.com.tw

Locations

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Taiwan
Yuan's General Hospital	Recruiting
Kaohsiung, Taiwan, 806
Contact: shuoying dai 0928257828 hsnu_10@yahoo.com.tw

Sponsors and Collaborators

National Cheng-Kung University Hospital

Yuan's General Hospital

More Information

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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

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Dai, Shuoying, National Cheng-Kung University Hospital:


post-operative analgesia ERAS (Enhanced Recovery After Surgery) pigtail chest tube

Additional relevant MeSH terms:

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Pain, Postoperative Acute Pain Postoperative Complications	Pathologic Processes Pain Neurologic Manifestations

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