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Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery

Primary Purpose

Post Operative Pain, Acute, Post-Op Complication, Opioid Use, Unspecified

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
uniportal VATS
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain, Acute focused on measuring post-operative analgesia, ERAS (Enhanced Recovery After Surgery), pigtail, chest tube

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yuan's General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

14-Fr pigtail catheter after uniportal VATS

20-Fr chest tube after uniportal VATS

Arm Description

smaller catheter used after uniportal VATS

routine management after uniportal VATS

Outcomes

Primary Outcome Measures

The VAS (Visual Analogue Scale)
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
cumulative intravenous morphine consumption
if there is any episodes of nausea or vomiting episodes that needs mediaction
related to anesthesia or analgesia.

Secondary Outcome Measures

pleural drainage from chest tube or pigtail, which was recorded by nurse.
after uniportal VATS (Video-Assisted Thoracic Surgery)
if there is any timepoint for need of conversion to tube thoracotomy from pigtail catheter
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)
the timing of chest tube removal and length of hospital stays

Full Information

First Posted
August 26, 2023
Last Updated
September 21, 2023
Sponsor
National Cheng-Kung University Hospital
Collaborators
Yuan's General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06050551
Brief Title
Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Yuan's General Hospital

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Acute, Post-Op Complication, Opioid Use, Unspecified, ERAS, Uniportal Video-Assisted Thoracic Surgery (VATS)
Keywords
post-operative analgesia, ERAS (Enhanced Recovery After Surgery), pigtail, chest tube

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
14-Fr pigtail catheter after uniportal VATS
Arm Type
Experimental
Arm Description
smaller catheter used after uniportal VATS
Arm Title
20-Fr chest tube after uniportal VATS
Arm Type
Other
Arm Description
routine management after uniportal VATS
Intervention Type
Procedure
Intervention Name(s)
uniportal VATS
Intervention Description
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.
Primary Outcome Measure Information:
Title
The VAS (Visual Analogue Scale)
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.
Time Frame
after operation 0, 2, 4, 8, 24, 48 hours
Title
morphine usage
Description
cumulative intravenous morphine consumption
Time Frame
in the first 24 hours after operation,
Title
if there is any episodes of nausea or vomiting episodes that needs mediaction
Description
related to anesthesia or analgesia.
Time Frame
after operation 0, 2, 4, 8, 24, 48 hours
Secondary Outcome Measure Information:
Title
pleural drainage from chest tube or pigtail, which was recorded by nurse.
Description
after uniportal VATS (Video-Assisted Thoracic Surgery)
Time Frame
after operation 24, 48, 72, 96 hours
Title
if there is any timepoint for need of conversion to tube thoracotomy from pigtail catheter
Description
related to post-operative complications, such as massive pleural effusion, pneumothorax, unstable vital signs or respiratory failure
Time Frame
after operation 24, 48, 72, 96 hours
Title
post-operative care after uniportal VATS (Video-Assisted Thoracic Surgery)
Description
the timing of chest tube removal and length of hospital stays
Time Frame
after operation 24, 48, 72, 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shuoying dai
Phone
0928257828
Email
hsnu_10@yahoo.com.tw
Facility Information:
Facility Name
Yuan's General Hospital
City
Kaohsiung
ZIP/Postal Code
806
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shuoying dai
Phone
0928257828
Email
hsnu_10@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery

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