Video Assisted Thoracoscopic SurgeryNCT07020624
Serratus Posterior Superior Intekcostal Plane Block vs Serratus Anterior Plane Block for Postoperative Analgesia in VATS: A Randomized Trial"
A study testing SAPB and SPSIPB in people with Video Assisted Thoracoscopic Surgery and Postoperative Analgesia, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy is known as one of the most painful surgical procedures, with up to 65% of patients developing chronic post-thoracotomy pain syndrome (PTPS), and approximately 10% experiencing pain that significantly impacts quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video Assisted Thoracoscopic Surgery, Postoperative Analgesia
- What is being tested?
- SAPB and SPSIPB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI < 35 kg/m² Patients with ASA scores I, II, III
Who cannot join
- Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site Patients whose surgical procedure time exceeds 150 minutes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Samsun University,
Samsun, Ilkadım, 55100
gamze ertaş, specialist, 5056587914, gamzertas.md@hotmail.com
hamiyet şenol çakmak, specialist
About this study
Official title: Comparison of the Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Serratus Anterior Plane Block (SAPB) on Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)
Thoracotomy is known as one of the most painful surgical procedures, with up to 65% of patients developing chronic post-thoracotomy pain syndrome (PTPS), and approximately 10% experiencing pain that significantly impacts quality of life. Video-assisted thoracoscopic surgery (VATS) has become increasingly common over the past decade and offers reduced postoperative pain, morbidity, and length of hospital stay compared to open thoracotomy. However, VATS can still cause moderate to severe postoperative pain and a high risk of chronic pain. Optimizing analgesia after VATS remains critical. With advances in ultrasound technology, several regional anesthesia techniques such as serratus anterior plane block (SAPB), erector spinae plane block (ESPB), and thoracic epidural analgesia (TEA) have shown comparable efficacy. In 2023, Tulgar et al. described the serratus posterior superior intercostal plane block (SPSIPB), which demonstrated dermatomal coverage from C3 to T10. This randomized controlled trial aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing VATS procedures.
Read the detailed description
The patients will be divided into two groups and all will receive general anesthesia. Before extubation, one group will receive a Serratus Anterior Plane Block, and the other group will receive a Serratus Posterior Superior Intercostal Plane Block. The randomization of the study will be performed by a physician who will not be involved in the patient follow-up, using a computer-generated randomization code (generated by the computer). The interfascial plane block (Serratus Anterior Plane Block or Serratus Posterior Superior Intercostal Plane Block) will be given to the anesthesiologist in a sealed envelope by an independent assistant personnel outside the study. The patient will not be aware of which block is being applied. The anesthesiologist performing the block will not participate in the patients' pain monitoring. Postoperative pain assessment and data collection will be performed by another anesthesiologist who is unaware of the study.
For standardization purposes, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 successful and uncomplicated procedures before.
- Being tested
- SAPB, SPSIPB
- Keywords
- serratus posterior superior intercostal plane block, Video-assisted thoracoscopic surgery, serratus anterior plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPBOther
Ultrasound guided serratus anterior plane block will be performed.
SPSIPBOther
Ultrasound guided serratus posterior superior intercostal plane block will be performed.
| Study group | Role | What they receive |
|---|---|---|
| group serratus anterior plane block (SAP) | Active comparator | At the end of the surgery, ultrasound-guided serratus anterior plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed Receives: Other: SAPB |
| group serratus posterior superior intercostal plane block(SPSIP) | Active comparator | At the end of the surgery, ultrasound-guided serratus posterior superior intercostal plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed Receives: Other: SPSIPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours postoperatively
Morfin consumption in the first 24 hours after surgery
Measured: up to 24 hours
Secondary outcomes (4)
Pain density
NRS scores (Numeric rating scale; 0: no pain, 10: severe pain) in the first 24 hours after surgery
Measured: up to 24 hours.
Quality of recovery
QR15 scores
Measured: 24 hours after surgery
Nausea and vomiting
Nausea and vomiting scores in the first 24 hours (verbal rating scale; 0= none, 1= nausea, 2= gagging, 3= vomiting)
Measured: up to 24 hours
shoulder pain
postoperative shoulder pain;shoulder pain will be evaluated as present/absent
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion1 Aug 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 Thoracoscopic SurgeryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two interventional group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hamiyet şenol çakmak, specialist, Principal investigator, samsun university Samsun Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020624
- Sponsor's protocol ID
- SPSIPB
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Serratus Anterior Plane Block (SAPB) on Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT07020624
- Acronym / sponsor ID
- SPSIPB
- Keywords
- serratus posterior superior intercostal plane block, Video-assisted thoracoscopic surgery, serratus anterior plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 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.
Thoracotomy is known as one of the most painful surgical procedures, with up to 65% of patients developing chronic post-thoracotomy pain syndrome (PTPS), and approximately 10% experiencing pain that significantly impacts quality of life. Video-assisted thoracoscopic surgery (VATS) has become increasingly common over the past decade and offers reduced postoperative pain, morbidity, and length of hospital stay compared to open thoracotomy. However, VATS can still cause moderate to severe postoperative pain and a high risk of chronic pain. Optimizing analgesia after VATS remains critical. With advances in ultrasound technology, several regional anesthesia techniques such as serratus anterior plane block (SAPB), erector spinae plane block (ESPB), and thoracic epidural analgesia (TEA) have shown comparable efficacy. In 2023, Tulgar et al. described the serratus posterior superior intercostal plane block (SPSIPB), which demonstrated dermatomal coverage from C3 to T10. This randomized controlled trial aims to compare the analgesic efficacy of SPSIPB and SAPB in patients undergoing VATS procedures.
Detailed description
The patients will be divided into two groups and all will receive general anesthesia. Before extubation, one group will receive a Serratus Anterior Plane Block, and the other group will receive a Serratus Posterior Superior Intercostal Plane Block. The randomization of the study will be performed by a physician who will not be involved in the patient follow-up, using a computer-generated randomization code (generated by the computer). The interfascial plane block (Serratus Anterior Plane Block or Serratus Posterior Superior Intercostal Plane Block) will be given to the anesthesiologist in a sealed envelope by an independent assistant personnel outside the study. The patient will not be aware of which block is being applied. The anesthesiologist performing the block will not participate in the patients' pain monitoring. Postoperative pain assessment and data collection will be performed by another anesthesiologist who is unaware of the study.
For standardization purposes, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 successful and uncomplicated procedures before.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two interventional group
| Arm | Type | Receives |
|---|---|---|
| group serratus anterior plane block (SAP) | Active comparator | Other: SAPBAt the end of the surgery, ultrasound-guided serratus anterior plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed |
| group serratus posterior superior intercostal plane block(SPSIP) | Active comparator | Other: SPSIPBAt the end of the surgery, ultrasound-guided serratus posterior superior intercostal plane block is performed with 0.25% bupivacaine. Perioperative and postoperative routine analgesic protocol is applied (consisting of intravenous analgesics and intravenous patient-controlled analgesia) without additional intervention (block) Standard Pain Monitoring and Follow-up is performed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI < 35 kg/m² Patients with ASA scores I, II, III
Key exclusion criteria (1 listed)
- Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site Patients whose surgical procedure time exceeds 150 minutes
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 |
|---|---|---|
| SAPBUltrasound guided serratus anterior plane block will be performed. | Other | group serratus anterior plane block (SAP) |
| SPSIPBUltrasound guided serratus posterior superior intercostal plane block will be performed. | Other | group serratus posterior superior intercostal plane block(SPSIP) |
Primary outcome
Morphine consumption in the first 24 hours postoperatively
Time frame: up to 24 hours
Morfin consumption in the first 24 hours after surgery
4 secondary outcomes
Pain density
Time frame: up to 24 hours.
Quality of recovery
Time frame: 24 hours after surgery
Nausea and vomiting
Time frame: up to 24 hours
shoulder pain
Time frame: up to 24 hours
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 13 Jun 2025.
- 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.
hamiyet şenol çakmak, specialist principal investigator
samsun university Samsun Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAPB and SPSIPB in people with Video Assisted Thoracoscopic Surgery and Postoperative Analgesia, run by Samsun 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 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?
Contact gamze ertaş, specialist (5056587914, gamzertas.md@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption in the first 24 hours postoperatively (time frame: up to 24 hours). 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 13 Jun 2025.