Video Assisted Thoracic Surgery (VATS)NCT06689449
Comparison Effects of Three Regional Anesthetic Technique on Pain During Video-assisted Thorascopic Surgery(VATS)
An observational study of Video Assisted Thoracic Surgery (VATS), run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video Assisted Thoracic Surgery (VATS)
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 20 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: ASA group 2-3-4 patients older than 18 years of age who will under go video assisted thoracic surgery
Who may be able to join
- 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.
Who cannot join
- Patients under age of 18
- Patients undergo surgery under general anesthesia
- Patients undergo emergency surgery
- Patients allergic to local anesthesia
- Patients wit bleeding diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Video Assisted Thoracic Surgery (VATS)
- Keywords
- video assisted thoracic surgery, erector spinae plan block, paravertebral block, mid-point transverse process to pleura block, analgesia nosiseption index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (1)
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
Measured: ıntraoperative and postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start20 Nov 2024
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracic Surgery (VATS)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689449
- Sponsor's protocol ID
- 2024/165
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06689449
- Acronym / sponsor ID
- 2024/165
- Conditions
- Video Assisted Thoracic Surgery (VATS)
- Keywords
- video assisted thoracic surgery, erector spinae plan block, paravertebral block, mid-point transverse process to pleura block, analgesia nosiseption index
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ASA group 2-3-4 patients older than 18 years of age who will under go video assisted thoracic surgery
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients under age of 18
- Patients undergo surgery under general anesthesia
- Patients undergo emergency surgery
- Patients allergic to local anesthesia
- Patients wit bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effective analgesia control in patients with Analgesia Nociception Index(ANI)
Time frame: intraoperative
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.
1 secondary outcome
Visual analog scale
Time frame: ıntraoperative and postoperative 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Video Assisted Thoracic Surgery (VATS), run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective analgesia control in patients with Analgesia Nociception Index(ANI) (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.