Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision

Study Overview
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Brief Summary
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Prospective, randomized, case-controlled trial study. Observation post-operatively: Aims: This study aimed to compare the effectiveness of the caudal block CB with other methods of postoperative pain release.

Detailed Description
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a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting on 1 May 2023. The patients will be divided into three groups: A caudal block(CB), B systemic opioids, and C dorsal penile block (DPNB) Techniques used in pediatric surgeries to provide analgesia for penile surgery such as circumcision. All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three groups. Pain scores were recorded by separate anesthesiologists or nurses in the post-anesthesia care unit. All statistical work will be carried out using Spss version 27 (Spss Inc., Chicago, USA) and Prism GraphPad version 9.4.1 (GraphPad, San Diego, USA) The categorical and numerical variables and demographic data of three groups were collected and reviewed by two authors. the study has shown that the caudal block produces higher levels of analgesia and a longer period of pain release than the penile block, even if both methods help relieve pain during pediatric surgical procedures.

Official Title
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Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision: A Prospective Randomized Study

Conditions
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Analgesia, Pain, Postoperative, Pain, Acute

Intervention / Treatment
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* Procedure: caudal block
* Procedure: Dorsal Penile Nerve Block DPNB
* Drug: Systemic opioids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Physical Status classification one aged from three months up to three years Exclusion Criteria: allergic to local anesthetics, bleeding diatheses, coagulopathy, infection at the injection site,

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group B systemic opioids for pain relive<br>systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous. | Procedure: caudal block<br>* The caudal block involves the injection of a local anesthetic Bupivacaine dose of 0.75 to 1 ml/kg the maximum volume was 10 mL with 0.25% concentration into the caudal epidural space, targeting the sacral nerve roots. to provide a high effect and duration of analgesia<br>* Other names: Regional anesthesia intervention;Procedure: Dorsal Penile Nerve Block DPNB<br>* DPNB is A type of pain control post-operative, often performed as a circumferential infiltration of the root of the penis (ring block). Two skin wheals are raised at the dorsal base of the penis, one on each side just below and medial to the pubic spine. A 25-gauge, 37.5-mm needle is introduced on each side, and the bupivacaine (1 to 1.5 mL) maximum dose 2 ml concentration 0.25% for infants is injected superficially and deep along the lower border of the pubic ramus to anesthetize the dorsal nerve. For a complete ring of infiltration,<br>* Other names: Regional anesthesia intervention.;Drug: Systemic opioids<br>* Systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.<br>* Other names: opioids analgesic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain assessment | The circumcision of children is the most commonly performed surgical procedure in the world Likely, the greatest target for us as anesthesiologists is to control the pain postoperatively. Various techniques are used to manage pain. Two of these techniques are CB and DPNB, both considered as regional blocks and involve the administration of local anesthesia. Additionally, systemic opioids have shown potential for alleviating postoperative pain. This study aimed to explore the benefits and limitations of these techniques and provide insights into their effectiveness and impact on circumcised patients. By evaluating the use of CB, penile block, and opioids, we can recognize their usefulness in promoting safe and painless circumcision surgery.Considering the risk points, DPNB can cause hematoma, opioids can lead to respiratory depression plus nausea and vomiting, while CB can cause delayed micturition, failed block, and cerebrospinal fluid aspiration due to puncture of dura | immediately after the intervention/procedure/surgery | 
| Pain postoperative assessment tools in post anesthesia care unit. | To gather information, a questionnaire consisting of two sections, the first section, demographic characteristics including age, and weight, and the second section consisting analgesia scale was used.This tool assesses pain in pediatric patients, preverbal children, and those who cannot express their pain verbally or accurately and is dependent on the assessment by the researcher based on the criteria of this scale. In this project, zero is analgesia, 1-3 is for mild pain, 4-6 is for moderate pain, and 7-10 is for severe pain the Face Legs a useful tool for parents to detect pain in their infants and young children. and toddlers | 20 minutes after the intervention/procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between children pain scale after 6h | Face, Legs, Activity, Cry, Consolability (FLACC) analgesia scale was used . The scores were observed and recorded during the first 5 min post op then 20 min, 30 min, and 60 min in Post Anesthesia Care unit. this scale is a standard tool to measure pain severity in which pain severity is scored from zero (analgesia) to 10 (maximum pain). This tool assesses pain in pediatric patients, preverbal children, and those who cannot express their pain verbally or accurately and is dependent on the assessment by the researcher based on the criteria of this scale. In this project, zero is analgesia, 1-3 is for mild pain, 4-6 is for moderate pain, and 7-10 is for severe pain .the pain scores were recorded at the various time points, postoperative analgesia between children pain scores after 6hours | Differences between children who underwent circumcision' surgery with or without caudal block anesthesia in the average pain scores at the various time points, postoperative analgesia between children pain scores after 6hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Pain Management, pediatric