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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023547
Receipt No. R000027084
Scientific Title Ultrasound guided quadratus lumborum block compared to caudal morphine in children undergoing surgery for vesicoureteric reflux
Date of disclosure of the study information 2016/08/08
Last modified on 2018/02/08

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Basic information
Public title Ultrasound guided quadratus lumborum block compared to caudal morphine in children undergoing surgery for vesicoureteric reflux
Acronym quadratus lumborum block for vesicoureteric reflux
Scientific Title Ultrasound guided quadratus lumborum block compared to caudal morphine in children undergoing surgery for vesicoureteric reflux
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Sato
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
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
1st name
Middle name
Last name Makoto Sato
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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