UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound guided quadratus lumborum block compared to caudal morphine in children undergoing surgery for vesicoureteric reflux
Title of the study (Brief title)	quadratus lumborum block for vesicoureteric reflux
Region	Japan

Condition
Condition	Vesicoureteric reflux
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare quadratus lumborum block group with caudal-morphine group in children undergoing surgery for vesicoureteric reflux from the aspect of perioperative analgesia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of analgesics 24 hours after surgery
Key secondary outcomes	The amount of analgesics in perioperative periods, pain score, incidence of complication at 0, 4, 24, 48 hours after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The computer randomly assign patients to the quadratus lumborum block group (Group Q, n=20) or the caudal morphine group (Group C, n=20). Patient is blinded from the administration. In Group Q, the ultrasound-guided quadratus lumborum block is performed under general anesthesia. One mg/kg of 0.2% ropivacaine are administered on both sides. General anesthesia are induced including continuous infusion of propofol, 0.5-1 mcg /kg/min remifentanil, and 0.6 mg/kg rocuronium and followed by tracheal intubation. Propofol are modurated to maintain the bispectral index within the recommended range (45-65). For intraoperative analgesia, 0.1-0.5 mcg /kg/min remifentanil are titrated and 4mcg /kg intravenous fentanyl are administered. All patients are extubated at the end of surgery, and a continuous infusion of fentanyl are started in the operating room at 0.2mcg/kg/h using Parent/Nurse Controlled Analgesia(PNCA) device (bolus dose 0.2mcg/kg, lock-out time 15 min) and continued on the ward. All infusions are continued for 48 h.
Interventions/Control_2	The computer randomly assign patients to the quadratus lumborum block group (Group Q, n=20) or the caudal morphine group (Group C, n=20). Patient is blinded from the administration. In Group C, the conventional caudal block is performed under general anesthesia. Two mg/kg of 0.2% ropivacaine are administered. General anesthesia are induced including continuous infusion of propofol, 0.5-1 mcg /kg/min remifentanil, and 0.6 mg/kg rocuronium and followed by tracheal intubation. Propofol are modurated to maintain the bispectral index within the recommended range (45-65). For intraoperative analgesia, 0.1-0.5 mcg /kg/min remifentanil are titrated and 4mcg /kg intravenous fentanyl are administered. All patients are extubated at the end of surgery, and a continuous infusion of fentanyl are started in the operating room at 0.2mcg/kg/h using Parent/Nurse Controlled Analgesia(PNCA) device (bolus dose 0.2mcg/kg, lock-out time 15 min) and continued on the ward. All infusions are continued for 48 h.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients who undergoing surgery for vesicoureteric reflux
Key exclusion criteria	Patients who have had analgesics, allergy of local anesthetics, past same operation, anatomical abnormalities at the site of nerve block, infection at the site of nerve block, neurological abnormalities, severe heart and/or renal failure, vasopressors in the operation, continuous unstable hemodynamic parameter (sBP>200, sBP<80, HR<40), disagreement with our study.
Target sample size	40

Research contact person
Name of lead principal investigator	Makoto Sato
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa,Japan
TEL	+81-90-6992-1409
Email	satomako@asahikawa-med.ac.jp

Public contact
Name of contact person	Makoto Sato
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa,Japan
TEL	+81-90-6992-1409
Homepage URL
Email	satomako@asahikawa-med.ac.jp

Sponsor
Institute	Department of Anesthesiology, Chiba Children's Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉県こども病院

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2018 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027084