Pectus ExcavatumNCT07697222
SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
An observational study of Pectus Excavatum and Chest Deformities, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pectus Excavatum, Chest Deformities
- What is being tested?
- Postoperative Analgesia Protocol, Bispectral Index Monitoring and Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2026to Jun 2027
- How long will I take part?
- 7 Days
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will include patients aged 15 to 25 years who are diagnosed with pectus excavatum and scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia. Patients who receive either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care will be included.
Who may be able to join
- Patients aged 15 to 25 years
- Diagnosis of pectus excavatum
- Scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia
- Receipt of either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care
- Written informed consent obtained from the patient or, for patients younger than 18 years, from a legal guardian
Who cannot join
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Known allergy to local anesthetics or study analgesic medications
- Chronic opioid use
- Pre-existing chronic pain syndrome
- Coagulopathy or use of anticoagulant therapy that contraindicates regional block application
Show all 10Show fewer
- Local infection at the block injection site
- Neurological or psychiatric condition that may interfere with pain assessment
- Incomplete perioperative or postoperative data
- Conversion to another surgical technique or major intraoperative complication requiring a change in the routine analgesic protocol
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, 1 recruiting
- Recruiting
Marmara University
Istanbul, Istanbul, 34722
Cem Özdemir, MD, +905385027687, suskungeveze.cem@gmail.com
Seniyye Ülgen Zengin, Associate Professor, MD, +905057142443, ulgen_t@yahoo.com
About this study
Official title: Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block After Minimally Invasive Repair of Pectus Excavatum: A Prospective Observational Cohort Study
This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block. The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.
Read the detailed description
Pectus excavatum is the most common chest wall deformity in pediatric and adolescent patients and is characterized by posterior depression of the sternum and anterior chest wall. Although many patients are asymptomatic, corrective surgery is frequently performed during adolescence or young adulthood for cosmetic reasons and to improve body image and quality of life.
Minimally invasive repair of pectus excavatum involves the placement of a curved metal bar beneath the sternum. The bar is then rotated to elevate the sternum and correct the chest wall deformity. Despite favorable cosmetic and quality-of-life outcomes, postoperative pain remains a major clinical challenge after this procedure. Pain is mainly related to sternal elevation, pressure exerted by the bar, and repositioning of the ribs. Inadequate pain control may increase opioid consumption and prolong hospitalization. Higher opioid exposure may also lead to adverse effects such as nausea, vomiting, constipation, pruritus, and urinary retention.
Regional anesthesia techniques have become important components of multimodal postoperative analgesia in thoracic surgery. Thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are among the regional techniques commonly used for thoracic analgesia. Serratus anterior plane block has also been used for postoperative pain management after minimally invasive repair of pectus excavatum.
Serratus posterior superior intercostal plane block is a recently described ultrasound-guided interfascial plane block. The technique involves injection of local anesthetic between the serratus posterior superior muscle and the rib, usually at the level of the second or third rib. This block has been reported to provide analgesia in various thoracic and scapular pain conditions and has shown promising results in thoracic surgery.
The aim of this study is to compare the postoperative analgesic outcomes of serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing minimally invasive repair of pectus excavatum. Because this is an observational study, the choice of regional analgesia technique will not be determined by the study protocol. The block technique will be selected by the attending anesthesiologist according to routine clinical practice. No randomization or protocol-driven assignment will be performed.
- Conditions
- Pectus Excavatum, Chest Deformities
- Being tested
- Postoperative Analgesia Protocol, Bispectral Index Monitoring, Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block
- Keywords
- Pectus excavatum, Serratus Anterior Plane Block, Serratus Posterior Superior Intercostal Plane Block, Opioid-Free Anesthesia, Multimodal Analgesia, SAP Block, SPSIP Block, Postoperative Pain, Opioid-Related Adverse Effects, Opioid Consumption, Chest Deformity Surgery, Regional Anesthesia
- Medical subject headings
- Funnel Chest, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Analgesia ProtocolDrug
All participants will receive a standardized multimodal postoperative analgesia protocol. Patient-controlled analgesia with intravenous morphine will be used. The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes. Paracetamol will be administered as part of routine multimodal analgesia. If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need.
Bispectral Index MonitoringDevice
Also called BIS, BIS Monitoring
Continuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Also called SPSIP Block, SPSIPB
Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.
Serratus Anterior Plane BlockProcedure or surgery
Also called SAP Block, SAPB
Bilateral ultrasound-guided serratus anterior plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plane Block Group | Participants in this cohort will receive bilateral ultrasound-guided serratus anterior plane block as part of routine perioperative analgesic care. Receives: Drug: Postoperative Analgesia Protocol; Device: Bispectral Index Monitoring; Procedure: Serratus Anterior Plane Block | |
| Serratus Posterior Superior Intercostal Plane Block Group | Participants in this cohort will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block as part of routine perioperative analgesic care. Receives: Drug: Postoperative Analgesia Protocol; Device: Bispectral Index Monitoring; Procedure: Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption during the first 24 hours
Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.
Measured: From the end of surgery to 24 hours postoperatively
Secondary outcomes (8)
Intraoperative opioid consumption
Total intraoperative opioid consumption will be recorded.
Measured: From induction of anesthesia to the end of surgery
Postoperative pain scores
Pain intensity will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
Patient satisfaction
Patient satisfaction with postoperative analgesia will be assessed using a 4-point Likert scale, where 0 indicates very dissatisfied and 3 indicates very satisfied.
Measured: At postoperative 6, 12, 24, and 48 hours
Incidence of Opioid-Related Adverse Effects
Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the two groups.
Measured: From the end of surgery to 48 hours postoperatively
Duration of anesthesia
The total duration of anesthesia will be recorded in minutes.
Measured: Intraoperative period
Duration of surgery
The total duration of surgery will be recorded in minutes.
Measured: Intraoperative period
Time to mobilization
The time from the end of surgery to first mobilization will be recorded.
Measured: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Length of hospital stay
The duration of postoperative hospitalization will be recorded.
Measured: Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start22 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulgen Zengin, Marmara University
- Investigators
- Cem Özdemir, MD, Study chair, Marmara UniversitySeniyye Ülgen Zengin, Associate Professor, MD, Principal investigator, Marmara UniversityMeliha Orhon Ergün, Associate Professor, MD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697222
- Sponsor's protocol ID
- 09.2026.769
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block After Minimally Invasive Repair of Pectus Excavatum: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07697222
- Acronym / sponsor ID
- 09.2026.769
- Conditions
- Pectus Excavatum, Chest Deformities
- Keywords
- Pectus excavatum, Serratus Anterior Plane Block, Serratus Posterior Superior Intercostal Plane Block, Opioid-Free Anesthesia, Multimodal Analgesia, SAP Block, SPSIP Block, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block. The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.
Detailed description
Pectus excavatum is the most common chest wall deformity in pediatric and adolescent patients and is characterized by posterior depression of the sternum and anterior chest wall. Although many patients are asymptomatic, corrective surgery is frequently performed during adolescence or young adulthood for cosmetic reasons and to improve body image and quality of life.
Minimally invasive repair of pectus excavatum involves the placement of a curved metal bar beneath the sternum. The bar is then rotated to elevate the sternum and correct the chest wall deformity. Despite favorable cosmetic and quality-of-life outcomes, postoperative pain remains a major clinical challenge after this procedure. Pain is mainly related to sternal elevation, pressure exerted by the bar, and repositioning of the ribs. Inadequate pain control may increase opioid consumption and prolong hospitalization. Higher opioid exposure may also lead to adverse effects such as nausea, vomiting, constipation, pruritus, and urinary retention.
Regional anesthesia techniques have become important components of multimodal postoperative analgesia in thoracic surgery. Thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are among the regional techniques commonly used for thoracic analgesia. Serratus anterior plane block has also been used for postoperative pain management after minimally invasive repair of pectus excavatum.
Serratus posterior superior intercostal plane block is a recently described ultrasound-guided interfascial plane block. The technique involves injection of local anesthetic between the serratus posterior superior muscle and the rib, usually at the level of the second or third rib. This block has been reported to provide analgesia in various thoracic and scapular pain conditions and has shown promising results in thoracic surgery.
The aim of this study is to compare the postoperative analgesic outcomes of serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing minimally invasive repair of pectus excavatum. Because this is an observational study, the choice of regional analgesia technique will not be determined by the study protocol. The block technique will be selected by the attending anesthesiologist according to routine clinical practice. No randomization or protocol-driven assignment will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Anterior Plane Block Group | – | Drug: Postoperative Analgesia Protocol, Device: Bispectral Index Monitoring, Procedure: Serratus Anterior Plane BlockParticipants in this cohort will receive bilateral ultrasound-guided serratus anterior plane block as part of routine perioperative analgesic care. |
| Serratus Posterior Superior Intercostal Plane Block Group | – | Drug: Postoperative Analgesia Protocol, Device: Bispectral Index Monitoring, Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants in this cohort will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block as part of routine perioperative analgesic care. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will include patients aged 15 to 25 years who are diagnosed with pectus excavatum and scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia. Patients who receive either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care will be included.
Key inclusion criteria (5 listed)
- Patients aged 15 to 25 years
- Diagnosis of pectus excavatum
- Scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia
- Receipt of either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care
- Written informed consent obtained from the patient or, for patients younger than 18 years, from a legal guardian
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Known allergy to local anesthetics or study analgesic medications
- Chronic opioid use
- Pre-existing chronic pain syndrome
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 |
|---|---|---|
| Postoperative Analgesia ProtocolAll participants will receive a standardized multimodal postoperative analgesia protocol. Patient-controlled analgesia with intravenous morphine will be used. The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes. Paracetamol will be administered as part of routine multimodal analgesia. If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need. | Drug | Serratus Anterior Plane Block Group, Serratus Posterior Superior Intercostal Plane Block Group |
| Bispectral Index MonitoringAlso: BIS, BIS MonitoringContinuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed. | Device | Serratus Anterior Plane Block Group, Serratus Posterior Superior Intercostal Plane Block Group |
| Serratus Posterior Superior Intercostal Plane BlockAlso: SPSIP Block, SPSIPBBilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| Serratus Anterior Plane BlockAlso: SAP Block, SAPBBilateral ultrasound-guided serratus anterior plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg. | Procedure or surgery | Serratus Anterior Plane Block Group |
Primary outcome
Total postoperative opioid consumption during the first 24 hours
Time frame: From the end of surgery to 24 hours postoperatively
Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.
8 secondary outcomes
Intraoperative opioid consumption
Time frame: From induction of anesthesia to the end of surgery
Postoperative pain scores
Time frame: At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
Patient satisfaction
Time frame: At postoperative 6, 12, 24, and 48 hours
Incidence of Opioid-Related Adverse Effects
Time frame: From the end of surgery to 48 hours postoperatively
Duration of anesthesia
Time frame: Intraoperative period
Duration of surgery
Time frame: Intraoperative period
Time to mobilization
Time frame: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Length of hospital stay
Time frame: Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
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 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
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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.
Cem Özdemir, MD study chair
Marmara University
Seniyye Ülgen Zengin, Associate Professor, MD principal investigator
Marmara University
Meliha Orhon Ergün, Associate Professor, MD study director
Marmara University
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 Pectus Excavatum and Chest Deformities, run by Marmara 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 5 inclusion and 10 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 13 Jul 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 Cem Özdemir, MD (+905385027687, suskungeveze.cem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative opioid consumption during the first 24 hours (time frame: From the end of surgery to 24 hours postoperatively). 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 Jul 2026.