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

NCT06050551 | Unknown

• 1 other identifier: 20221108B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  after operation 0, 2, 4, 8, 24, 48 hours

• morphine usage

  cumulative intravenous morphine consumption

  in the first 24 hours after operation,

• if there is any episodes of nausea or vomiting episodes that needs mediaction

  related to anesthesia or analgesia.

  after operation 0, 2, 4, 8, 24, 48 hours

Secondary Outcomes (3)

• pleural drainage from chest tube or pigtail, which was recorded by nurse.

  after operation 24, 48, 72, 96 hours

• if there is any timepoint for need of conversion to tube thoracotomy from pigtail catheter

  after operation 24, 48, 72, 96 hours

• post-operative care after uniportal VATS (Video-Assisted Thoracic Surgery)

  after operation 24, 48, 72, 96 hours

Study Arms (2)

14-Fr pigtail catheter after uniportal VATS

EXPERIMENTAL

smaller catheter used after uniportal VATS

Procedure: uniportal VATS

20-Fr chest tube after uniportal VATS

OTHER

routine management after uniportal VATS

Procedure: uniportal VATS

Interventions

uniportal VATS PROCEDURE

1. 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.) 2. thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation, 3. routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need.

14-Fr pigtail catheter after uniportal VATS; 20-Fr chest tube after uniportal VATS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- eighty consecutive adult patients undergoing elective uniportal VATS lobectomy

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Yuan's General Hospital: collaborator

Study Sites (1)

Yuan's General Hospital

Kaohsiung City, 806, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

shuoying dai

CONTACT

0928257828; hsnu_10@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, attending physician

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 22, 2023
• Study Start: March 8, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)