NCT06436755

Brief Summary

The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2025

Completed
Last Updated

February 5, 2025

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

May 15, 2024

Last Update Submit

February 4, 2025

Conditions

Keywords

Transversus thoracic muscle plane blockpostoperative analgesiapectus excavatum

Outcome Measures

Primary Outcomes (3)

  • Effect of Serratus Anterior Plane Block and Transthoracic Plane Block Combination on Postoperative Analgesia in Pectus Surgery

    Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, TTP block will be added to the SAP block in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery. The patient's pain score will be evaluated with the Numerical Rating Scale (NRS). Hourly pain scores in the postoperative period are 0./1./4./6./12./18./24./48. Additional complications

    postoperative 48 hours

  • Postoperative Analgesia in Pectus Surgery

    Total amount of analgesia for 48 hours,

    postoperative 48 hours

  • Postoperative pain in Pectus Surgery

    Presence of need for additional analgesics,

    postoperative 48 hours

Study Arms (2)

Serratus anterior plane block (SAP) group

Patients who underwent serratus anterior plane block

Procedure: no intervention,this is a observational studies

Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) group

Patients who underwent Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) group

Procedure: no intervention,this is a observational studies

Interventions

no intervention,this is a observational studies

Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) groupSerratus anterior plane block (SAP) group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients over the age of 15 who will be operated on due to pectus deformity

You may qualify if:

  • Patients who will undergo surgery due to pectus deformity All patients over the age of 15 who will be operated on due to pectus deformity

You may not qualify if:

  • Known allergy to local anesthetics,
  • Uncooperative patient,
  • The patient who refuses to participate in the study,
  • Patients under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, İ̇stanbul, 34480, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

CANSU KILINÇ BERKTAŞ

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist MD

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 31, 2024

Study Start

September 1, 2024

Primary Completion

November 21, 2025

Study Completion

November 21, 2025

Last Updated

February 5, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations