Clinical trial NCT01869036: Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery
Official title: Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery - Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Caudal
Keywords: Caudal
anesthesia
morphine
children
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: statistical diffirence in intraoperative and postoperative narcotic requirements + filling of the pain assessment questionnaire
timeFrame: at the end of operation (anesthesiological report) and at the end of 1 post-op day (nurse report)
Secondary outcomes:
measure: Side-effects measuring
timeFrame: during operation and within 1 post-op day
Other outcomes:
Locations:
city: Jerusalem,
country: Israel
facility: The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
Study officials:
affiliation: Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
name: Boris Chertin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayhew JF, Brodsky RC, Blakey D, Petersen W. Low-dose caudal morphine for postoperative analgesia in infants and children: a report of 500 cases. J Clin Anesth. 1995 Dec;7(8):640-2. doi: 10.1016/0952-8180(95)00089-5.
citation: Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
citation: Singh R, Kumar N, Singh P. Randomized controlled trial comparing morphine or clonidine with bupivacaine for caudal analgesia in children undergoing upper abdominal surgery. Br J Anaesth. 2011 Jan;106(1):96-100. doi: 10.1093/bja/aeq274. Epub 2010 Oct 14.
citation: Cesur M, Alici HA, Erdem AF, Yapanoglu T, Silbir F. Effects of reduction of the caudal morphine dose in paediatric circumcision on quality of postoperative analgesia and morphine-related side-effects. Anaesth Intensive Care. 2007 Oct;35(5):743-7. doi: 10.1177/0310057X0703500514.