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

Phase 4

Completed

• Conditions: Anesthesia, Caudal
• Interventions: Drug: caudal anesthesia supplemented with morphine; Drug: caudal anesthesia

• Registration Number: NCT01869036
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-05
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
caudal anesthesia supplemented with morphine	caudal anesthesia supplemented with morphine	-
caudal anesthesia	caudal anesthesia	-

Primary Outcome Measures

Name	Time	Method
statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire	at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)	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.

Secondary Outcome Measures

Name	Time	Method
Side-effects measuring	during operation and within 1 post-op day	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.

Trial Locations

Locations (1)

The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University; 🇮🇱 Jerusalem,, Israel