Vergelijking van de effecten van sacrale erector spinae vlakke blok en dorsaal penisblok op postoperatieve pijn bij besnijdenisprocedures
Vergelijking van de effecten van sacrale erector spinae vlakke blok en dorsaal penisblok op postoperatieve pijn bij besnijdenisoperaties
Egypt performed circumcision in 2300 BC, although its origin is unknown. Some societies use circumcision for health, whereas others do it for religious and cultural reasons . Our competent pediatric surgeons perform circumcisions without ultrasonography using midazolam (0.1 mg/kg) premedication and penile block. In addition to penile block, general anesthesia is given using sevoflurane, ketamine, fentanyl, and propofol, depending on age and weight, for intraoperative anesthesia and analgesia. Penis procedures are frequently simple (phimosis, circumcision), but the pain is significant and long-lasting, affecting young patients' postoperative recovery. The topic of analgesia remains relevant and important in anesthesia practice. Early patient mobilization and discharge are crucial. Pediatric opioid use is questioned due to adverse effects include somnolence, vomiting, and respiratory depression. The advent of ultrasound-guided nerve blocks has revolutionized regional anesthesia in pediatrics. Many upper and lower abdominal operations use truncal blocks with good success and patient safety. Since its applicability, ease of anatomical approach, distance to the medulla spinalis and surgical site, and minimal risk of infection, sacral ESP block has become a popular method for youngsters. Postoperative pain trials demonstrate it works well.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Although it is not known exactly where it was first performed, there is evidence that the Egyptians performed circumcision in 2300 BC. While circumcision is performed for health reasons in some societies, it is a traditional, religious and cultural practice in some. In our clinic, circumcision cases are performed with anesthesia monitoring and premedication with midazolam (0.1 mg/kg) followed by penile block, which is our clinical practice, by experienced pediatric surgeons who perform the surgical procedure without the use of ultrasound. In addition to penile block in standard practice, general anesthesia is applied to patients with sevoflurane, ketamine, fentanyl and propofol, depending on the patient's age and weight, depending on the need for intraoperative anesthesia and analgesia. Postoperative pain after surgeries on the penis is a problem that directly affects postoperative recovery in young patients because the surgical procedure itself is often minor (treatment of phimosis, circumcision), whereas the pain produced is both severe and long-lasting.
The need for analgesia is a topic that always occupies anesthesia practice and maintains its relevance. It is vital to ensure early mobilization and discharge of patients. Many side effects, including somnolence, vomiting and respiratory depression, call into question the use of opioids in pediatrics.
Today, the use of ultrasound-guided nerve block has resulted in a revolutionary change in the field of regional anesthesia in pediatrics. Many truncal blocks are used with a high success rate in both upper and lower abdominal surgeries and have become standard in terms of patient safety.
Sacral ESP block, especially applied in children, has become an increasingly important technique due to its advantages such as applicability, ease of anatomical approach, distance to the medulla spinalis and surgical site, and low risk of infection. In addition, studies have shown that it is quite effective in postoperative pain.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Meram
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Konya, Meram, Turkije (Türkiye), 42140
- Yasin Tire
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
The study population consists of pediatric patients aged 7 to 12 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective circumcision surgery under general anesthesia. All participants are required to be able to communicate pain perception reliably. Written informed consent will be obtained from parents or legal guardians prior to enrollment.
Beschrijving
**Inclusion Criteria:**
- Age 7 to 12 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Scheduled to undergo elective circumcision under general anesthesia.
- Ability to communicate pain using the study pain assessment tools.
- Written informed consent obtained from a parent or legal guardian.
**Exclusion Criteria:**
- Refusal or inability of the parent/legal guardian or participant (when appropriate) to provide informed consent or assent.
- American Society of Anesthesiologists (ASA) Physical Status III or higher.
- Emergency surgery.
- History of significant hematologic, cardiovascular, hepatic, or renal disease.
- Current anticoagulant therapy.
- Known hypersensitivity or allergy to local anesthetic agents.
- Previous penile surgery.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Group P (Penile Block)
Patients who underwent Dorsal Penile Block after circumcision surgery |
P arm: Patients who underwent Dorsal Penile Block after circumcision surgery |
|
Group S (Sacral ESP Block)
Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery |
S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PRIMARY OUTCOME
Tijdsspanne: From admission to the post-anesthesia care unit through postoperative hour 6.
|
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity and therefore a worse outcome. Pain assessments will be performed upon admission to the post-anesthesia care unit and at 30-minute intervals during the post-anesthesia care unit stay, followed by assessments at postoperative hours 1, 2, 4, and 6 or until hospital discharge, whichever occurs first. |
From admission to the post-anesthesia care unit through postoperative hour 6.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
SECONDARY OUTCOME
Tijdsspanne: Postoperative hour 6.
|
Parents will assess their child's postoperative pain before hospital discharge using a 4-point Simple Pain Scale. Scores range from 0 to 3, where 0 indicates no pain or a calm child, 1 indicates minimal pain or an irritable child, 2 indicates mild pain or a consolable child, and 3 indicates severe pain or an inconsolable child. Higher scores indicate greater pain intensity and therefore a worse outcome. |
Postoperative hour 6.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
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Trefwoorden
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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