Lung Cancer (NSCLC)NCT07002788
Comparison Paravertebral and Serratus Anterior Plane Block in Video-assisted Thoracoscopic Surgery.
A study testing Bupivacaine, Morphine and Paracetamol in people with Lung Cancer (NSCLC) and Lung Adenocarcinoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive alternative to thoracotomy that emerged in the early 1990s, aiming to reduce surgical stress and postoperative pain. While VATS generally results in less pain than thoracotomy, patients may still experience significant discomfort. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer (NSCLC), Lung Adenocarcinoma, Video Assisted Thoracic Surgery (VATS)
- What is being tested?
- Bupivacaine, Morphine and Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jan 2026
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-64 who gave consent to participate in the study
- Patients between the ages of 65-90 who received a score of 24 or more from the mini mental test and gave consent to participate in the study
- ASA 1-3 patients
Who cannot join
- Those with neuropathy,
- Those with renal failure,
- Those with liver failure,
- Those with coagulopathy,
- Those with local anesthetic allergy,
- Those with infection in the area where the procedure will be performed,
- Those with congenital muscle absence in the area where the block will be performed
- Patients who did not give consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Paravertebral Block and Serratus Anterior Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive alternative to thoracotomy that emerged in the early 1990s, aiming to reduce surgical stress and postoperative pain. While VATS generally results in less pain than thoracotomy, patients may still experience significant discomfort. Effective pain control remains crucial in VATS to minimize postoperative complications, especially pulmonary and cardiac events, which can arise from inadequate ventilation and impaired sputum clearance due to pain.
Various strategies have been developed to manage postoperative pain, with multimodal approaches-combining regional or peripheral blocks with systemic analgesics such as NSAIDs and adjuvants-now considered standard. Among regional techniques, serratus anterior plane (SAP) block and thoracic paravertebral block (PVB) are commonly used. SAP block targets the thoracodorsal, long thoracic, and T2-T9 spinal nerves between the latissimus dorsi and serratus anterior muscles, providing effective anterolateral chest wall analgesia. PVB targets intercostal nerves within the paravertebral space and has shown superior pain control and improved lung function compared to systemic opioids or intrapleural local anesthetics.
Read more
At our center, both SAP and PVB are routinely used for postoperative analgesia in VATS procedures for patients with lung masses. Pain levels will be assessed using the Visual Analog Scale (VAS), a reliable tool for evaluating both acute and chronic pain, unaffected by age or gender.
This study aims to compare the effectiveness of SAP and PVB blocks in terms of postoperative pain, opioid requirements, and block-related complications in patients undergoing VATS under general anesthesia. The research is observational and will not alter routine clinical practices.
Read the detailed description
The study is a single-center randomized single-blind prospective clinical study, and after patients with appropriate criteria are included in the study; they will be assigned to either the paravertebral block arm or the serratus anterior plane block arm of the study using an internet-based randomization program (randomizer.org). Patients will not know which arm of the study they are in, but researchers who will evaluate the treatment outcome will know which block was applied to which patient. Paravertebral block or serratus anterior plane block will be applied to the patients under general anesthesia after VATS according to the arm they are in. After the patients are taken to the room, non-invasive arterial blood pressure, electrocardiogram, and peripheral oxygen saturation monitoring will be performed before general anesthesia. This is the routine monitoring method applied before anesthesia application. Standard routine general anesthesia will be applied to the patients. No change will be made in the general anesthesia approach due to the study.
- Being tested
- Bupivacaine, Morphine, Paracetamol, Diklofenak Sodyum
- Keywords
- paravertebral block, serratus anterior plane block, lung cancer, video-assisted thoracoscopic surgery
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivakain
Used for regional anesthesia during VATS procedure (e.g., paravertebral or serratus anterior plane block)
MorphineDrug
Also called morfin
Used for postoperative pain control via PCA device.
ParacetamolDrug
Also called Acetaminophen
Used as part of postoperative multimodal analgesia
Diklofenak SodyumDrug
Also called NSAID
Administered for postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Active comparator | Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography. Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Paracetamol; Drug: Diklofenak Sodyum |
| serratus anterior plane block | Active comparator | In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound. Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Paracetamol; Drug: Diklofenak Sodyum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores (VAS)
Pain assessment will be performed by Res. Asst. Dr. Rabia Çakmak at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Pain scores will be evaluated at rest and during coughing using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Measured: Within the first 24 hours after surgery
Total Postoperative Morphine Consumption
Total morphine consumption in the first 24 hours after surgery will be recorded by the patient-controlled analgesia (PCA) device.
Measured: Within the first 24 hours after surgery
Secondary outcomes (1)
Total Rescue Analgesic Use
Amount of additional analgesic medication (excluding PCA-administered morphine) required in the first 24 hours postoperatively will be recorded.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat İzgi, Hacettepe University
- Investigators
- murat izgi, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002788
- Sponsor's protocol ID
- KA-24035
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only results
Publications
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Gagliese L, Katz J. Age differences in postoperative pain are scale dependent: a comparison of measures of pain intensity and quality in younger and older surgical patients. Pain. 2003 May;103(1-2):11-20. doi: 10.1016/s0304-3959(02)00327-5.
PubMed 12749954Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.
PubMed 32734596Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.
PubMed 34739134
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Paravertebral Block and Serratus Anterior Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT07002788
- Acronym / sponsor ID
- KA-24035
- Keywords
- paravertebral block, serratus anterior plane block, lung cancer, video-assisted thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive alternative to thoracotomy that emerged in the early 1990s, aiming to reduce surgical stress and postoperative pain. While VATS generally results in less pain than thoracotomy, patients may still experience significant discomfort. Effective pain control remains crucial in VATS to minimize postoperative complications, especially pulmonary and cardiac events, which can arise from inadequate ventilation and impaired sputum clearance due to pain.
Various strategies have been developed to manage postoperative pain, with multimodal approaches-combining regional or peripheral blocks with systemic analgesics such as NSAIDs and adjuvants-now considered standard. Among regional techniques, serratus anterior plane (SAP) block and thoracic paravertebral block (PVB) are commonly used. SAP block targets the thoracodorsal, long thoracic, and T2-T9 spinal nerves between the latissimus dorsi and serratus anterior muscles, providing effective anterolateral chest wall analgesia. PVB targets intercostal nerves within the paravertebral space and has shown superior pain control and improved lung function compared to systemic opioids or intrapleural local anesthetics.
At our center, both SAP and PVB are routinely used for postoperative analgesia in VATS procedures for patients with lung masses. Pain levels will be assessed using the Visual Analog Scale (VAS), a reliable tool for evaluating both acute and chronic pain, unaffected by age or gender.
This study aims to compare the effectiveness of SAP and PVB blocks in terms of postoperative pain, opioid requirements, and block-related complications in patients undergoing VATS under general anesthesia. The research is observational and will not alter routine clinical practices.
Detailed description
The study is a single-center randomized single-blind prospective clinical study, and after patients with appropriate criteria are included in the study; they will be assigned to either the paravertebral block arm or the serratus anterior plane block arm of the study using an internet-based randomization program (randomizer.org). Patients will not know which arm of the study they are in, but researchers who will evaluate the treatment outcome will know which block was applied to which patient. Paravertebral block or serratus anterior plane block will be applied to the patients under general anesthesia after VATS according to the arm they are in. After the patients are taken to the room, non-invasive arterial blood pressure, electrocardiogram, and peripheral oxygen saturation monitoring will be performed before general anesthesia. This is the routine monitoring method applied before anesthesia application. Standard routine general anesthesia will be applied to the patients. No change will be made in the general anesthesia approach due to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Paracetamol, Drug: Diklofenak SodyumParavertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography. |
| serratus anterior plane block | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Paracetamol, Drug: Diklofenak SodyumIn patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18-64 who gave consent to participate in the study
- Patients between the ages of 65-90 who received a score of 24 or more from the mini mental test and gave consent to participate in the study
- ASA 1-3 patients
Key exclusion criteria (8 listed)
- Those with neuropathy,
- Those with renal failure,
- Those with liver failure,
- Those with coagulopathy,
- Those with local anesthetic allergy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: BupivakainUsed for regional anesthesia during VATS procedure (e.g., paravertebral or serratus anterior plane block) | Drug | Paravertebral block, serratus anterior plane block |
| MorphineAlso: morfinUsed for postoperative pain control via PCA device. | Drug | Paravertebral block, serratus anterior plane block |
| ParacetamolAlso: AcetaminophenUsed as part of postoperative multimodal analgesia | Drug | Paravertebral block, serratus anterior plane block |
| Diklofenak SodyumAlso: NSAIDAdministered for postoperative pain management | Drug | Paravertebral block, serratus anterior plane block |
Primary outcome
Postoperative Pain Scores (VAS)
Time frame: Within the first 24 hours after surgery
Pain assessment will be performed by Res. Asst. Dr. Rabia Çakmak at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Pain scores will be evaluated at rest and during coughing using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Total Postoperative Morphine Consumption
Time frame: Within the first 24 hours after surgery
Total morphine consumption in the first 24 hours after surgery will be recorded by the patient-controlled analgesia (PCA) device.
1 secondary outcome
Total Rescue Analgesic Use
Time frame: Within the first 24 hours after surgery
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 4 Jun 2025.
- Background: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- Background: PubMed 12749954Gagliese L, Katz J. Age differences in postoperative pain are scale dependent: a comparison of measures of pain intensity and quality in younger and older surgical patients. Pain. 2003 May;103(1-2):11-20. doi: 10.1016/s0304-3959(02)00327-5.
- Background: PubMed 32734596Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.
- Background: PubMed 34739134Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.
- Link directs to a related article on the American Academy of Pain Medicine website, providing further details regarding the study's methodology and findings.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only results
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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.
murat izgi principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Morphine and Paracetamol in people with Lung Cancer (NSCLC) and Lung Adenocarcinoma, run by Hacettepe 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 3 inclusion and 8 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 4 Jun 2025. 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?
Postoperative Pain Scores (VAS) (time frame: Within the first 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002788, which also lists 4 linked publications.
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 4 Jun 2025.