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Postoperative PainNCT07850388

Pain Control and Recovery After Thoracic Surgery Using SPSIP Block

An observational study of Postoperative Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Thoracic surgery is frequently associated with significant postoperative pain, which may impair respiratory function, mobilization, recovery, and patient satisfaction. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block that may provide… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Type of treatment
Surgery or procedure
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2026to 1 Apr 2028
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults undergoing elective minor VATS, major VATS, or thoracotomy under general anesthesia who receive SPSIP block as part of routine multimodal analgesia

Who may be able to join

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thoracic surgery
  • Undergoing minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy
  • Planned ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine multimodal analgesia
  • Able and willing to provide written informed consent

Who cannot join

  • Patient refusal
  • Known allergy to amide local anesthetics
  • Coagulopathy
  • Therapeutic anticoagulation incompatible with regional anesthesia
  • Infection at the planned block injection site
  • Pregnancy
Show all 11Show fewer
  • Emergency surgery
  • Chronic opioid therapy for more than 3 months
  • Chronic pain syndrome
  • Cognitive impairment that prevents reliable study assessments
  • Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Murat Aksun, M.D. contact

+90 552 363 16 14

murataksun@yahoo.com

Ahmet Salih Tüzen, M.D. contact

+90 535 391 55 77

astuzen@icloud.com

Turkey (Türkiye)1 site, 1 recruiting
  • Izmir Katip Celebi University Atatürk Training and Research Hospital, Karabaglar, Izmir

    Izmir, İzmir, 35360

    Bilgesu Kaya Çalış, M.D., +90 5398795124, bilgesukaya2@gmail.com

    Murat Aksun, M.D.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Analgesic Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Among Different Thoracic Surgical Procedures: A Prospective Observational Cohort Study

Thoracic surgery is frequently associated with significant postoperative pain, which may impair respiratory function, mobilization, recovery, and patient satisfaction. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block that may provide effective analgesia after thoracic surgery. This prospective observational cohort study will evaluate the analgesic effectiveness and postoperative recovery associated with SPSIP block in adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy. All patients will receive SPSIP block as part of routine institutional multimodal analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include postoperative pain intensity, opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, pulmonary complications, patient satisfaction, length of hospital stay, and chronic postoperative pain.

Read the detailed description

Postoperative pain remains an important clinical concern following thoracic surgery. Inadequate analgesia may adversely affect deep breathing, coughing, pulmonary toilet, early mobilization, and overall postoperative recovery. Although minimally invasive thoracic surgical techniques have reduced surgical trauma, clinically relevant postoperative pain may still occur. Regional anesthesia techniques are commonly incorporated into multimodal analgesic strategies for thoracic surgery. Fascial plane blocks have emerged as alternatives to more invasive regional techniques because of their relative technical simplicity and potential safety advantages. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block with promising analgesic efficacy; however, evidence regarding whether its effectiveness differs according to the invasiveness of the thoracic surgical procedure remains limited.

This prospective observational cohort study will include adult patients undergoing elective thoracic surgery under general anesthesia who receive an ultrasound-guided SPSIP block as part of routine institutional multimodal analgesia. Patients will be categorized according to the surgical procedure into three predefined cohorts: minor video-assisted thoracoscopic surgery (VATS), major VATS, and thoracotomy. The SPSIP block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic. No participant will be assigned to a surgical procedure or regional anesthesia technique for research purposes.

The primary objective is to compare postoperative quality of recovery among the three surgical cohorts. Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15) at 24 hours after surgery, with higher scores indicating better postoperative recovery.

Secondary outcomes will include postoperative opioid consumption expressed as morphine milligram equivalents, pain intensity measured using the Numeric Rating Scale at rest and during coughing, time to first rescue analgesia, total rescue analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, hemodynamic variables, pulmonary complications, time to ambulation, length of hospital stay, and patient satisfaction. Pain intensity will be evaluated in the post-anesthesia care unit and at 2, 6, 12, and 24 hours after surgery. Patients will also be followed for clinically relevant postoperative outcomes, including hospital readmission within 30 days and chronic postoperative pain at 3 and 6 months. Potential block-related complications, including local anesthetic systemic toxicity, pneumothorax, hematoma, and infection, will be recorded.

The study is designed to determine whether postoperative recovery and analgesic outcomes associated with the same SPSIP block technique differ according to the type and invasiveness of thoracic surgery.

Being tested
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Keywords
Serratus Posterior Superior Intercostal Plane Block, Thoracic Surgery, Regional Anesthesia, Postoperative Analgesia, Quality of Recovery-15
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery

    An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.

Study groups in NCT07850388
Study groupRoleWhat they receive
Minor VATSAdult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Receives: Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Major VATSAdult patients undergoing elective major video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Receives: Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
ThoracotomyAdult patients undergoing elective thoracotomy under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Receives: Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Recovery-15 Score at 24 Hours

    Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better postoperative recovery. QoR-15 scores will be compared among the minor VATS, major VATS, and thoracotomy cohorts.

    Measured: 24 hours after surgery

Secondary outcomes (23)
  1. Total Opioid Consumption During the First 24 Postoperative Hours

    Total opioid consumption during the first 24 hours after surgery will be calculated and converted to morphine milligram equivalents (MME) to allow comparison among the three surgical cohorts.

    Measured: 0 to 24 hours after surgery

  2. Pain Intensity at Rest Upon Admission to the PACU

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: Upon admission to the post-anesthesia care unit (PACU)

  3. Pain Intensity at Rest at 2 Hours

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 2 hours after the end of surgery

  4. Pain Intensity at Rest at 6 Hours

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 6 hours after the end of surgery

  5. Pain Intensity at Rest at 12 Hours

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 12 hours after the end of surgery

  6. Pain Intensity at Rest at 24 Hours

    Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 24 hours after the end of surgery

  7. Pain Intensity During Coughing Upon Admission to the PACU

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: Upon admission to the post-anesthesia care unit (PACU)

  8. Pain Intensity During Coughing at 2 Hours

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 2 hours after the end of surgery

  9. Pain Intensity During Coughing at 6 Hours

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 6 hours after the end of surgery

  10. Pain Intensity During Coughing at 12 Hours

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 12 hours after the end of surgery

  11. Pain Intensity During Coughing at 24 Hours

    Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

    Measured: 24 hours after the end of surgery

  12. Time to First Rescue Analgesic Administration

    Time from completion of surgery to the first administration of rescue analgesic medication will be recorded.

    Measured: 0 to 24 hours after surgery

  13. Total Rescue Analgesic Requirement

    The total amount of rescue analgesic medication administered during the postoperative observation period will be recorded.

    Measured: 0 to 24 hours after surgery

  14. Incidence of Postoperative Nausea and Vomiting

    The number of participants experiencing postoperative nausea and/or vomiting will be recorded.

    Measured: 0 to 24 hours after surgery

  15. Requirement for Rescue Antiemetic Medication

    The number of participants requiring rescue antiemetic medication will be recorded.

    Measured: 0 to 24 hours after surgery

  16. Time to First Postoperative Ambulation

    Time from the end of surgery to the patient's first postoperative ambulation will be recorded in hours. First ambulation will be defined as the first documented occasion on which the patient gets out of bed and ambulates with or without assistance. Patients who do not ambulate before hospital discharge will be considered not to have experienced the event during the observation period.

    Measured: From the end of surgery until first postoperative ambulation or hospital discharge, whichever occurs first, assessed up to 30 days after surgery.

  17. Postoperative Length of Hospital Stay

    The duration of postoperative hospitalization will be recorded in days, calculated from the end of surgery until hospital discharge.

    Measured: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

  18. Chronic Postoperative Pain at 3 Months

    Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 3 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 3 months after surgery

  19. Chronic Postoperative Pain at 6 Months

    Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 6 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 6 months after surgery

  20. Hospital Readmission Within 30 Days

    The number of participants requiring unplanned hospital readmission within 30 days after surgery will be recorded.

    Measured: Within 30 days after surgery

  21. Incidence of SPSIP Block-Related Complications

    The number of participants who develop one or more complications related to the Serratus Posterior Superior Intercostal Plane (SPSIP) block will be recorded. Complications will include local anesthetic systemic toxicity, pneumothorax attributable to the block, hematoma at the block site, and infection at the block site.

    Measured: From block performance until hospital discharge, assessed up to 30 days after surgery.

  22. Incidence of Postoperative Pulmonary Complications

    Postoperative pulmonary complications will include pneumonia, clinically significant atelectasis requiring therapeutic intervention, bronchospasm requiring treatment, aspiration pneumonitis, acute respiratory distress syndrome, postoperative respiratory failure requiring non-invasive ventilatory support or reintubation, or an unplanned escalation in respiratory support. Participants experiencing at least one of these events will be considered to have a postoperative pulmonary complication.

    Measured: From the end of surgery until hospital discharge, up to 30 days

  23. Patient Satisfaction With Postoperative Analgesia

    Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction with postoperative analgesia.

    Measured: 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.

  1. First posted30 Sep 2026
  2. Study start1 Oct 2026
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850388
Sponsor's protocol ID
2025-SAEK-0815
Status last verified
Nov 2026
First submitted
18 Sep 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data sharing is currently planned.

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Izmir Katip Celebi 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 11 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Murat Aksun, M.D. (+90 552 363 16 14, murataksun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 Score at 24 Hours (time frame: 24 hours after surgery). 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 3 Nov 2026.

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