Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorKonya City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Inclusion criteria of the patients: Age between 7-12 years, ASA Physical Status 1 and 2, circumcision surgery, general anesthesia, planned hospital stay of at least 24 hours.

Disqualifiers

Exclusion criteria were defined as patients whose family or personal consent could not be obtained for the study, Asa 3 and above cases, patients in the study age group who will undergo emergency surgery, patients with serious hematopoietic system, cardiovascular, liver or kidney disease, patients receiving anticoagulation therapy, patients with sensitivity to regional anesthetic agents and patients who have previously undergone penile surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PENILE BLOCK ARM

    Procedure/Surgery

    P arm: Patients who underwent Dorsal Penile Block after circumcision surgery

  • SACRAL ESP BLOCK ARM

    Procedure/Surgery

    S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group P (Penile Block)Active comparator 1 intervention
Group B: Group S (Sacral ESP Block)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PRIMARY OUTCOME

The primary outcome variable of the study will be the FLACC pain score transferred to the pacu after surgery. Patients will be assessed for pain with the FLACC pain scale at 30-minute intervals throughout the pacu stay and at 0, 1, 2, 4 and 6 hours until discharge from the hospital.

Time frame
Postoperative ''0 hour, 1. hour, 2.hour, 4.hour, 6 hour

Secondary outcomes

1

SECONDARY OUTCOME

As a secondary outcome variable, a simple pain scale was explained to parents to fill in the rating sheet as a measure of satisfaction with postoperative pain (0 = no pain/child calm; 1 = minimal pain/child irritable; 2 = mild pain/child consolable; and 3 = severe pain/child inconsolable).

Time frame
postoperative '' before the discharge''

Other outcomes

Sponsors and contacts

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