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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06050551
Other study ID # 20221108B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2023
Est. completion date December 1, 2024

Study information

Verified date September 2023
Source National Cheng-Kung University Hospital
Contact shuoying dai
Phone 0928257828
Email hsnu_10@yahoo.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Taiwan Yuan's General Hospital Kaohsiung

Sponsors (2)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital Yuan's General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary morphine usage cumulative intravenous morphine consumption in the first 24 hours after operation,
Primary 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 pleural drainage from chest tube or pigtail, which was recorded by nurse. after uniportal VATS (Video-Assisted Thoracic Surgery) after operation 24, 48, 72, 96 hours
Secondary 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 after operation 24, 48, 72, 96 hours
Secondary post-operative care after uniportal VATS (Video-Assisted Thoracic Surgery) the timing of chest tube removal and length of hospital stays after operation 24, 48, 72, 96 hours
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