Acute Post Operative PainNCT06778642
Postoperative Analgesic Comparison of SPSI Block and SAP Block in Video-Assisted Thoracoscopic Surgery (VATS)
A study testing Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in people with Acute Post Operative Pain, run by Uludag University.
Trial summary
In our study, we primarily aimed to compare the postoperative analgesic effectiveness of the Serratus Posterior Superior Intercostal Plane Block and the Serratus Anterior Plane Block, both routinely applied in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Post Operative Pain
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 10 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years undergoing Video-Assisted Thoracoscopic Surgery (VATS)
- Scheduled at Uludağ University Faculty of Medicine Hospital Operating Room
- Classified as ASA I, II, or III according to the American Society of Anesthesiologists (ASA) criteria
Who cannot join
- Allergy to local anesthetics or contraindications to bupivacaine
- Known or suspected coagulopathy
- Infection at the injection site
- History of thoracic surgery
- Severe neurological or psychiatric disorders
- Severe cardiovascular disease
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- Liver failure
- Renal failure (glomerular filtration rate < 15 ml/min/1.73 m²)
- Chronic opioid use
About this study
Official title: Comparison of the Postoperative Analgesic Effectiveness of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Video-Assisted Thoracoscopic Surgery (VATS)
In our study, we primarily aimed to compare the postoperative analgesic effectiveness of the Serratus Posterior Superior Intercostal Plane Block and the Serratus Anterior Plane Block, both routinely applied in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Read the detailed description
In Video-Assisted Thoracoscopic Surgery (VATS), the thoracic cavity is visualized through a small incision in the chest wall. VATS allows for procedures such as lobectomy, bullectomy, and wedge resection. Compared to thoracotomy, VATS offers lower costs, better pulmonary function, less pain, and earlier postoperative mobilization. The success of postoperative rehabilitation in thoracic surgery patients can be improved with minimally invasive procedures and effective pain control.
The multimodal analgesic approach, which involves the combined use of analgesic drugs with different mechanisms (NSAIDs, paracetamol, opioids, etc.) along with regional/local techniques, aims to achieve additive and synergistic effects. This approach reduces the need for high doses of a single analgesic, minimizes side effects, and provides more effective pain control.
Investigators routinely apply opioids, NSAIDs, paracetamol, intravenous patient-controlled analgesia (PCA) devices, and regional techniques such as thoracic paravertebral block, serratus anterior plane block (SAPB), serratus posterior superior intercostal plane block (SPSIPB), and erector spinae plane (ESP) block for postoperative pain management in VATS patients.
The primary objective of this study is to compare the effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Serratus Anterior Plane Block (SAPB), both routinely used in thoracic anesthesia practice, on postoperative pain scores and analgesic needs in VATS patients.
The SAPB, which is an essential component of multimodal analgesia in thoracic surgery, offers safe and precise analgesic effects with low complication rates. The block covers most VATS incisions and chest tube sites, providing better postoperative analgesia and potentially improving lung function. Similarly, SPSIPB, another thoracic wall fascial plane block, has been shown to be effective in managing both acute and chronic pain. It is reported to provide good analgesia in the thoracic region after VATS.
The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included.
Patients will be randomized into two groups:
Group 1: SPSIPB (n=45) Group 2: SAPB (n=45) Both blocks will be applied after standard anesthesia induction, intubation, surgical positioning, and before surgical incision.
During the intraoperative period, if heart rate or mean arterial pressure (MAP) increases by more than 20% from baseline measurements, IV fentanyl (1 µg/kg) will be administered as needed. Prior to the surgical incision, all patients will receive IV paracetamol (10 mg/kg), tenoxicam (20 mg), and metoclopramide (10 mg) as part of routine practice.
Fifteen minutes before awakening, a patient-controlled analgesia (PCA) device will be connected to each patient. The PCA device will be prepared with 1 mg/ml morphine solution, with a bolus dose of 2 ml and a lockout interval of 15 minutes. In patients with an NRS score of ≥4, IV tramadol (100 mg/2 ml) will be administered as a rescue analgesic. The pain score at the time of rescue analgesia, the time of the first PCA request, and the NRS score at that time will be recorded.
- Conditions
- Acute Post Operative Pain
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with bupivacaine after induction and before the surgical procedure begins.
Serratus Anterior Plane BlockProcedure or surgery
Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Anterior Plane Block (SAPB) with bupivacaine after induction and before the surgical procedure begins.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Active comparator | In this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The upper medial border of the scapula on the side of the planned surgery will be identified between the 2nd and 7th ribs. A block needle will be inserted medially to the scapula, advancing into the plane between the serratus posterior superior muscle and the intercostal muscles. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day. In other words, the injection will be applied under the SPS muscle, between the rib and the SPS muscle. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Serratus Anterior Plane Block Group | Active comparator | In this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The probe will be placed between the anterior and posterior axillary lines, on the side of the planned surgery, between the 2nd and 7th ribs. The block needle will be advanced to the surface or deeper part of the serratus anterior muscle, into the fascial plane. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day, underneath the serratus anterior muscle. Receives: Procedure: Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) The Numerical Rating Scale (NRS) is a commonly used pain assessment tool that allows patients to rate their pain intensity on a scale from 0 to 10.
0 indicates no pain. 10 indicates the worst possible pain. Patients are asked to choose a number that best represents their pain level at the time of assessment.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 May 2025 (estimated)
- Primary completion9 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post Operative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included. Patients will be randomized into two groups: Group 1: SPSIPB Group 2: SAPB
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Bayraktar Cabuk, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778642
- Sponsor's protocol ID
- UU-AN-RBC-01
- Status last verified
- May 2025
- First submitted
- 12 Jan 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effectiveness of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT06778642
- Acronym / sponsor ID
- UU-AN-RBC-01
- Conditions
- Acute Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 9 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 16 Jan 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.
In our study, we primarily aimed to compare the postoperative analgesic effectiveness of the Serratus Posterior Superior Intercostal Plane Block and the Serratus Anterior Plane Block, both routinely applied in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Detailed description
In Video-Assisted Thoracoscopic Surgery (VATS), the thoracic cavity is visualized through a small incision in the chest wall. VATS allows for procedures such as lobectomy, bullectomy, and wedge resection. Compared to thoracotomy, VATS offers lower costs, better pulmonary function, less pain, and earlier postoperative mobilization. The success of postoperative rehabilitation in thoracic surgery patients can be improved with minimally invasive procedures and effective pain control.
The multimodal analgesic approach, which involves the combined use of analgesic drugs with different mechanisms (NSAIDs, paracetamol, opioids, etc.) along with regional/local techniques, aims to achieve additive and synergistic effects. This approach reduces the need for high doses of a single analgesic, minimizes side effects, and provides more effective pain control.
Investigators routinely apply opioids, NSAIDs, paracetamol, intravenous patient-controlled analgesia (PCA) devices, and regional techniques such as thoracic paravertebral block, serratus anterior plane block (SAPB), serratus posterior superior intercostal plane block (SPSIPB), and erector spinae plane (ESP) block for postoperative pain management in VATS patients.
The primary objective of this study is to compare the effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Serratus Anterior Plane Block (SAPB), both routinely used in thoracic anesthesia practice, on postoperative pain scores and analgesic needs in VATS patients.
The SAPB, which is an essential component of multimodal analgesia in thoracic surgery, offers safe and precise analgesic effects with low complication rates. The block covers most VATS incisions and chest tube sites, providing better postoperative analgesia and potentially improving lung function. Similarly, SPSIPB, another thoracic wall fascial plane block, has been shown to be effective in managing both acute and chronic pain. It is reported to provide good analgesia in the thoracic region after VATS.
The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included.
Patients will be randomized into two groups:
Group 1: SPSIPB (n=45) Group 2: SAPB (n=45) Both blocks will be applied after standard anesthesia induction, intubation, surgical positioning, and before surgical incision.
During the intraoperative period, if heart rate or mean arterial pressure (MAP) increases by more than 20% from baseline measurements, IV fentanyl (1 µg/kg) will be administered as needed. Prior to the surgical incision, all patients will receive IV paracetamol (10 mg/kg), tenoxicam (20 mg), and metoclopramide (10 mg) as part of routine practice.
Fifteen minutes before awakening, a patient-controlled analgesia (PCA) device will be connected to each patient. The PCA device will be prepared with 1 mg/ml morphine solution, with a bolus dose of 2 ml and a lockout interval of 15 minutes. In patients with an NRS score of ≥4, IV tramadol (100 mg/2 ml) will be administered as a rescue analgesic. The pain score at the time of rescue analgesia, the time of the first PCA request, and the NRS score at that time will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included. Patients will be randomized into two groups: Group 1: SPSIPB Group 2: SAPB
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block Group | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane BlockIn this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The upper medial border of the scapula on the side of the planned surgery will be identified between the 2nd and 7th ribs. A block needle will be inserted medially to the scapula, advancing into the plane between the serratus posterior superior muscle and the intercostal muscles. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day. In other words, the injection will be applied under the SPS muscle, between the rib and the SPS muscle. |
| Serratus Anterior Plane Block Group | Active comparator | Procedure: Serratus Anterior Plane BlockIn this group, the ultrasound device with a linear probe (38 mm, 6 MHz) will be used. The probe will be placed between the anterior and posterior axillary lines, on the side of the planned surgery, between the 2nd and 7th ribs. The block needle will be advanced to the surface or deeper part of the serratus anterior muscle, into the fascial plane. A total of 30 ml of 0.25% bupivacaine will be injected, with a maximum dose of 2 mg/kg/day, underneath the serratus anterior muscle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 80 years undergoing Video-Assisted Thoracoscopic Surgery (VATS)
- Scheduled at Uludağ University Faculty of Medicine Hospital Operating Room
- Classified as ASA I, II, or III according to the American Society of Anesthesiologists (ASA) criteria
Key exclusion criteria (9 listed)
- Allergy to local anesthetics or contraindications to bupivacaine
- Known or suspected coagulopathy
- Infection at the injection site
- History of thoracic surgery
- Severe neurological or psychiatric disorders
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockPatients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with bupivacaine after induction and before the surgical procedure begins. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| Serratus Anterior Plane BlockPatients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Anterior Plane Block (SAPB) with bupivacaine after induction and before the surgical procedure begins. | Procedure or surgery | Serratus Anterior Plane Block Group |
Primary outcome
The Numerical Rating Scale (NRS)
Time frame: 2 days
Numerical Rating Scale (NRS) The Numerical Rating Scale (NRS) is a commonly used pain assessment tool that allows patients to rate their pain intensity on a scale from 0 to 10. 0 indicates no pain. 10 indicates the worst possible pain. Patients are asked to choose a number that best represents their pain level at the time of assessment.
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 15 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in people with Acute Post Operative Pain, run by Uludag University.
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 9 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The Numerical Rating Scale (NRS) (time frame: 2 days). 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 15 May 2025.