Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584201
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Effects of Erector Spina Plane Block and Paravertebral Block on Early Postoperative Pulmonary Function Test Parameters
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Erector Spina Plane Block and Paravertebral Block on Early Postoperative Pulmonary Function Test Parameters in Patients Undergoing Video-assisted Thoracoscopic Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pain experienced by participants after minimally invasive chest surgery VATS can make it difficult for them to take deep breaths which can lead to problems with lung function This can cause serious problems such as lung collapse low oxygen levels and infections making recovery longer and more difficult Managing pain well after surgery is important to prevent these problems and speed up recovery In this study we aimed to compare two pain relief methods Erector Spinae Plane Block ESP and Paravertebral Block PVB in participants who underwent VATS We will look at which method causes the smallest change in lung function before and after surgery
Detailed Description:
Video-assisted Thoracoscopic surgery VATS is a minimally invasive surgical method used in the diagnosis and treatment of diseases in the chest area Thoracoscopic surgery has many advantages such as being less invasive less risk of complications shorter hospital stay and better cosmetic results However these participants may experience severe pain in the postoperative period although not as much as in surgeries performed with open surgical methods that is thoracotomy This pain which occurs in the postoperative period in VATS methods which is one of the minimally invasive methods may prevent the participants from taking deep breaths as well as cause deterioration of respiratory functions serious pulmonary complications such as atelectasis hypoxia and infection and prolonged postoperative patient stay As the development of morbidity and mortality Delay or deterioration in postoperative respiratory functions is one of the most troublesome complications of thoracic surgery It was reported that acute pain in the postoperative period should be effectively controlled with effective analgesia methods in order to prevent postoperative pulmonary complications and accelerate the patients well-being Controlling pain with postoperative analgesia allows participants to breathe more deeply perform breathing exercises more effectively and therefore improves and helps preserve respiratory functions Although thoracic epidural analgesia is the gold standard method in thoracic surgery intravenous analgesic techniques and thoracic trunk nerve blocks are increasingly recommended for postoperative analgesia in less invasive VATS operations Thoracic trunk blocks have effects on hemodynamics respiratory functions and consciousness It has important advantages such as having fewer side effects than systemic analgesic techniques and being less invasive than thoracic epidural analgesia Body blocks are recommended as a first-line analgesia program especially in thoracic surgery as they shorten postoperative recovery time reduce the risk of pneumonia and provide early postoperative mobilization The ease of application of the erector spinae plane block ESP its low risk of complications and its ability to provide effective analgesia especially in minimally invasive surgeries have increased its use Paravertebral block PVB one of the other blocks is frequently used because it is more reliable and provides effective analgesia compared to thoracic epidural analgesia and conventional analgesia methods Thoracic trunk plane blocks can significantly reduce intravenous opioid use and prevent side effects related to opioid use with the effective analgesia they provide in the early postoperative period increase participants comfort and painlessness and accelerate recovery while preventing deterioration in respiratory function parameters during rest and mobilization Because It is thought that by applying erector spinae plane block ESP or paravertebral block PVB postoperative pain scores and opioid consumption will decrease significantly and respiratory functions will return earlier In this study we aimed to evaluate the effects of ESP or PVB on respiratory functions in the early postoperative period in patients undergoing VATS and in which block there would be less percentage change between preoperative and postoperative respiratory function test PFT parameters
Pain is a symptom known to be subjective and will be queried with a standardized scale the visual pain score scale VAS to minimize differences between participants Postoperative rest and movement pain scores VAS 0 1 2 4 6 12 24 and pre-discharge scores postoperative 6th hour 24th hour and predischarge pulmonary function test PFT parameters total Analgesic consumption will be recorded at 0 1 2 4 6 12 24 hours and before discharge
Forced Vital Capacity FVC Forced Expiratory Volume in 1 Second FEV1 FEV1FVC Peak Expiratory Flow PEF values will be recorded as Respiratory Function Test parameters
The total narcotic analgesic needs of the participants who received the block will be recorded with the PCA device placed intravenously postoperatively and their total Morphine consumption will be recorded
Participants satisfaction after the procedure will be questioned with a Likert score before discharge
Side effects such as nausea and vomiting that may occur in participants will be questioned with the simplified post-operative nausea and vomiting impact scale
Participants demographic characteristics comorbidities operation times and complications will be recorded and statistically analyzed
Pain is a symptom known to be subjective and will be queried with a standardized scale the visual pain score scale VAS to minimize differences between participants Postoperative rest and movement pain scores VAS 0 1 2 4 6 12 24 and pre-discharge scores postoperative 6th hour 24th hour and predischarge pulmonary function test PFT parameters total Analgesic consumption will be recorded at 0 1 2 4 6 12 24 hours and before discharge
Forced Vital Capacity FVC Forced Expiratory Volume in 1 Second FEV1 FEV1FVC Peak Expiratory Flow PEF values will be recorded as Respiratory Function Test parameters
The total narcotic analgesic needs of the participants who received the block will be recorded with the PCA device placed intravenously postoperatively and their total Morphine consumption will be recorded
Participants satisfaction after the procedure will be questioned with a Likert score before discharge
Side effects such as nausea and vomiting that may occur in participants will be questioned with the simplified post-operative nausea and vomiting impact scale
Participants demographic characteristics comorbidities operation times and complications will be recorded and statistically analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None