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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06436755
Other study ID # 2024-271
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date November 21, 2025

Study information

Verified date May 2024
Source Basaksehir Çam & Sakura City Hospital
Contact CANSU KILINÇ BERKTAS
Phone +9005542448087
Email cansukilinc87@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. It is very important for patients to start active breathing exercises and mobilize early. Complications develop less frequently in patients who actively breathe and mobilize early. The tolerability of the surgery by the patient and the absence of pain in the postoperative period ensure early discharge . 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date November 21, 2025
Est. primary completion date November 21, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: 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 Exclusion Criteria: - Known allergy to local anesthetics, - Uncooperative patient, - The patient who refuses to participate in the study, - Patients under 18 years of age.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
no intervention,this is a observational studies
no intervention,this is a observational studies

Locations

Country Name City State
Turkey Basaksehir Çam Ve Sakura Sehir Hastanesi Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Basaksehir Çam & Sakura City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Postoperative Analgesia in Pectus Surgery Total amount of analgesia for 48 hours, postoperative 48 hours
Primary Postoperative pain in Pectus Surgery Presence of need for additional analgesics, postoperative 48 hours
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