Comparison Effects of Three Regional Anesthetic Technique on Pain During Video-assisted Thorascopic Surgery(VATS)

Comparison Effects of Erector Spinae Plan Block(ESP), Paravertebral Block(PVB) and Mid-point Transverse Process to Pleura Block(MTP) on Perioperative Pain Measured With Analgesia Nociceptive Index Monitor on Video-assisted Thoracoscopic Surgey(VATS)

In this study, our iş to compare effect of erector spinae plan block(ESP), paravertebral block(PVB) and mid-point transverse process to pleura block(MTP) on perioperative pain measured with analgesia nociceptive index monitor on video-assisted thoracoscopic surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Video Assisted Thoracic Surgery (VATS)

Detailed Description

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive thoracic surgery procedure performed with the help of a retractor-free camera through small skin incisions used to diagnose and treat chest diseases. Many of the major procedures traditionally performed with open thoracoscopic surgery can be performed using smaller sections with video assistance.

Thanks to the advances in minimally invasive techniques, the non-intubated thoracoscopic approach has been adapted even for use with major lung resections.

An adequate analgesia obtained from regional anaesthesia techniques allows VATS to be performed in sedated patients and the potential adverse effects related to general anaesthesia and selective ventilation can be avoided. The non-intubated procedures try to minimize the adverse effects of tracheal intubation and general anaesthesia, such as intubation-related airway trauma, ventilation-induced lung injury, residual neuromuscular blockade, and postoperative nausea and vomiting.

Local anaesthetic techniques essential for nonentubeted video assisted thoracic surgery include thoracic epidural anaesthesia, cervical epidural anaesthesia, paravertebral block, intercostal nerve block, injection of local anaesthetic at the site of trocar incision local vagus blockade, erector spinae plane block, serratus anterior plane block and pectoralis nerve block.

Thoracic epidural analgesia, once considered the gold standard for thoracotomy; due to the risks of complications related to dural puncture, epidural hematoma, neuropathy and hypotension, it is no longer the first choice for VATS and has been replaced by peripheral blocks.

ANI is a monitor that can be measured continuously and non-invasively. It measures parasympathetic tone - based on electrocardiography - by analyzing minimal changes in heart rate that occur under anesthesia, in the early stages of awakening, and in each respiratory cycle of awake patients. At the end of the measurement, a value between 0-100 is obtained.

Parasympathetic modulation (stress level, e.g., pain) is obtained with a minimum value of 0 and a maximum of 100. ANI values measured in the early period of recovery correlate with pain scores. When compared with hemodynamic parameters, it has been reported that the ANI response is more sensitive to nociceptive stimuli occurring in the intraoperative period.

In the high-risk patient group who will undergoing video-assisted thoracoscopic surgery (VATS) in the Faculty of Medicine of Erciyes University, the pain sensation in patients will be evaluated using ANI in the perioperative period, after the peripheral nerve blocks have been applied to different anatomical areas that are routinely used.

The aim of this study is to objectively reveal the perioperative pain after peripheral block applications in the patient group with serious additional morbidities by using the ANI device. It is expected that this study will enable more effective analgesia control in patients.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Turkey
  • Kayseri̇
    • Kayseri, Kayseri̇, Turkey, 38039
      • Recep aksu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

ASA group 2-3-4 patients older than 18 years of age who will under go video assisted thoracic surgery

Description

Inclusion Criteria:

• Patient over the age of 18 under the 80 Who will undergo video assisted thoracic surgery -ASA group 2-3-4.
• Patients without opioid addiction.
• Patients without allergies.
• Patients without psychiatric disorder.
• Patients without arrhymia and beta-blocker use.
• Patients without contraindications for peripheral blocks.

Exclusion Criteria:

• Patients under age of 18
• Patients undergo surgery under general anesthesia
• Patients undergo emergency surgery
• Patients allergic to local anesthesia
• Patients wit bleeding diathesis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
erector spinae plan block group; The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signs before and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and an erector spinae plane block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.
paravertebral block group; The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signs before and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and a paravertebral block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.
mid-point transverse process to pleura block group; The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signsbefore and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and a mid-point transverse process to pleura block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective analgesia control in patients with Analgesia Nociception Index(ANI)	With Analgesia Nociception Index (ANI), it is advantageous to evaluate the objective findings measuring parasympathetic system activity. ANI is a monitor that can be measured continuously and non-invasively. It measures parasympathetic tone - based on electrocardiography - by analyzing minimal changes in heart rate that occur under anesthesia, in the early stages of awakening, and in each respiratory cycle of awake patients. A value between 0-100 is obtained, Values between 50 and 70 indicate good analgesia control. According to studies on ANI, the patient feels pain below 50. If it is above 70, it means that more analgesia is provided. It is thought that pain control will be more effective with these objective data.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale	A Visual Analogue Scale (VAS) is one of the pain rating scales. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest the VAS score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain	ıntraoperative and postoperative 24 hour

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: paravertebral block; erector spinae plan block; video assisted thoracic surgery; mid-point transverse process to pleura block; analgesia nosiseption index
• Other Study ID Numbers: 2024/165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No