Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery

Study Overview
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Brief Summary
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The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal anesthesia in children who undergo renal surgery in our department.

Detailed Description
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The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy. One of the main goals in the postoperative period is to provide a painless recovery following by early mobilization of the child and early discharge home. Caudal anesthesia has become a gold standard in the renal surgery providing painless postoperative period, allowing earlier child feeding and speedy recovery. However some researchers have pointed out that caudal anesthesia with supplemented with Marcaine may provide painless postoperative period only for a very limited period of time and required additional painkiller therapy during postoperative period. Caudal anesthesia supplemented with Morphine has demonstrated their benefits in children who undergo infraumbilical surgery.

Official Title
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Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery - Prospective Study

Conditions
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Anesthesia, Caudal

Intervention / Treatment
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* Drug: caudal anesthesia
* Drug: caudal anesthesia supplemented with morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children who are scheduled for renal surgery from two months age to puberty operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy Exclusion Criteria: malignancy

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: caudal anesthesia<br> | Drug: caudal anesthesia<br>* Standard caudal anesthesia (Marcaine 2mg/kg)<br>* Other names: sacral epidural anesthesia;|
| Active Comparator: caudal anesthesia supplemented with morphine<br> | Drug: caudal anesthesia supplemented with morphine<br>* Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire | The following parameters will be compared between two groups: the length of surgery, intraoperative and postoperative narcotic requirements. The children parents or children thyself will be asked to fill out the pain assessment questionnaire. | at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side-effects measuring | Side-effects such as vomiting, itching, respiratory depression, hypotension, and bradycardia will be observed. Oral intake and discharge home will be recorded. Complications rate will be recorded and compared between two groups. | during operation and within 1 post-op day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caudal, anesthesia, morphine, children