UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023547 |
|---|---|
| Receipt number | 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 09:23:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
satomako@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Chiba Children's Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027084
