CompletedNot Applicable

Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery

Turkey (Türkiye)68 participantsStarted 2022-12-21

Plain-language summary

The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane (ESP) block and caudal block in participants undergoing hypospadias surgery. Investigators will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA. In this study, investigators seek answers to the following questions: Which of the sacral (ESP) block and caudal block applied to participants undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other? Which of the sacral ESP block and caudal block applied to participants undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded. This research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 participnts from the ASA I-II pediatric participants aged between 6 months and 7 years, who will undergo hypospadias surgery between December 2022-December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 participants.

Who can participate

Age range

6 Months – 7 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * American Society of Anesthesiology (ASA) I-II group * 6 months to 7 years old * Paediatric age group patients who will undergo hypospadias surgery under general anesthesia Exclusion Criteria: * ASA III - IV patient group * Patients who were operated on urgently * Patient relatives who did not give consent * Presence of local anesthetic allergy * Presence of infection in the area to be blocked * Presence of coagulation disorder * Severe organ failure * Pre-existing neurological deficit * Mental Retardation * Anatomical Deformity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of the analgesia

Timeframe: 1 year

Trial details

NCT IDNCT05632536

SponsorSisli Hamidiye Etfal Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-18

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