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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038156
Receipt No. R000043489
Scientific Title Efficacy and Safety of Quadratus Lumborum Block and Rectus Sheath Block in Pediatric Patients: A Randomized Clinical Study and Pharmacokinetic Profile
Date of disclosure of the study information 2019/11/01
Last modified on 2019/09/30

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Basic information
Public title Efficacy and Safety of Quadratus Lumborum Block and Rectus Sheath Block in Pediatric Patients: A Randomized Clinical Study and Pharmacokinetic Profile
Acronym Efficacy and Safety of Quadratus Lumborum Block and Rectus Sheath Block in Pediatric Patients: A Randomized Clinical Study and Pharmacokinetic Profile
Scientific Title Efficacy and Safety of Quadratus Lumborum Block and Rectus Sheath Block in Pediatric Patients: A Randomized Clinical Study and Pharmacokinetic Profile
Scientific Title:Acronym Efficacy and Safety of Quadratus Lumborum Block and Rectus Sheath Block in Pediatric Patients: A Randomized Clinical Study and Pharmacokinetic Profile
Region
Japan

Condition
Condition Appendicitis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and safety of quadratus lumborum block combined with rectus sheath block in pediatric patients undergoing laparoscopic appendectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The maximum NRS score in 3 hours postoperatively
Key secondary outcomes The need for rescue analgesia, Face Scale, NRS score, the number of anesthetised dermatomes, and complications related to the use of local anesthetic in 48 hours postoperatively

The pharmacokinetic profile of levobupivacaine after nerve block for 2 hours

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 In all the patients, general anesthesia is induced using inhaled sevoflurane in an air-oxygen mixture, including 2mcg/kg fentanyl and 0.6 mg/kg rocuronium, followed by tracheal intubation.
The nerve blocks are performed after intubation prior to incision. In both groups, a high-frequency linear ultrasound probe with a sterile sheath is used to guide needle placement and/or to confirm the spread of the local anesthetic.
The patients in Group Q are placed in the supine position. The bilateral ultrasound guided quardratus lumborum block is performed via the in-plane, transverse, posterior approach described by Branco et al. A needle is inserted from the anterolateral to posteromedial direction, and levobupivacaine 0.25% 0.4 ml/kg is injected into the lumbar interfascial triangle along the dorsal side of the thoracolumbar fascia on one side. The block is then performed on the contralateral side (0.8 ml/kg 0.25% levopivacaine in total).
Surgery is started 15-30 min after performing the block. Any complications occurring intraoperatively are recorded in detail. General anesthesia is maintained by total intravenous anesthesia. Propofol is modulated to maintain the bispectral index within the recommended range (40-60). For intraoperative analgesia, remifentanil is adjusted to maintain the systolic blood pressure and heart rate within 20% of the pre-incision value, and 2 mcg/kg intravenous fentanyl is administered at the time of wound closure. All the patients are extubated at the end of the operation. Intravenous acetaminophen 15 mg /kg is administered to patients in both.
Interventions/Control_2 In all the patients, general anesthesia is induced using inhaled sevoflurane in an air-oxygen mixture, including 2mcg/kg fentanyl and 0.6 mg/kg rocuronium, followed by tracheal intubation.
The nerve blocks are performed after intubation prior to incision. In both groups, a high-frequency linear ultrasound probe with a sterile sheath is used to guide needle placement and/or to confirm the spread of the local anesthetic.
The patients in Group QR are placed in the supine position. First, the bilateral ultrasound guided quardratus lumborum block is performed via the in-plane, transverse, posterior approach described by Branco et al. A needle is inserted from the anterolateral to posteromedial direction, and levobupivacaine 0.25% 0.4 ml/kg is injected into the lumbar interfascial triangle along the dorsal side of the thoracolumbar fascia on one side. The block is then performed on the contralateral side (0.8 ml/kg 0.25% levopivacaine in total). Then, the bilateral ultrasound guided rectus sheath block is performed via the in-plane, transverse approach. A needle is inserted into the rectus sheath, and levobupivacaine 0.25% 0.2 ml/kg is injected on one side. The block is then performed on the contralateral side (0.4 ml/kg 0.25% levopivacaine in total).
Surgery is started 15-30 min after performing the block. Any complications occurring intraoperatively are recorded in detail. General anesthesia is maintained by total intravenous anesthesia. Propofol is modulated to maintain the bispectral index within the recommended range (40-60). For intraoperative analgesia, remifentanil is adjusted to maintain the systolic blood pressure and heart rate within 20% of the pre-incision value, and 2 mcg/kg intravenous fentanyl is administered at the time of wound closure. All the patients are extubated at the end of the operation. Intravenous acetaminophen 15 mg /kg is administered to patients in both.
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
7 years-old <=
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Children between the ages of 7 and 17 years undergoing laparoscopic appendectomy with American Society of Anesthesiologists (ASA) physical status of 1 or 2 are enrolled.
The child's parent or legal guardian is provided oral and written informed consent. Assent to participate in the study is also given by children.
Key exclusion criteria American Society of Anesthesiologists (ASA) physical status of 3 or higher
Allergy of local anesthetics
Anatomical abnormalities at the site of the nerve block
History of abdominal surgery
Preoperative analgesic administration
Neurological abnormalities at the site of the nerve block
Severe heart and/or renal failure (EF<40, Cre>1.0)
Coagulopathy
Additional procedures planned via a separate incision at the time of the laparoscopic appendectomy
Contraindications for any of the medications described in the protocol
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Sato
Organization Tokyo Metropolitan Children Medical Center
Division name Department of Anesthesiology
Zip code 1838561
Address Musashidai 2-8-29, Fuchu, Tokyo
TEL 0423005111
Email satomako1001@gmail.com

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Sato
Organization Tokyo Metropolitan Children Medical Center
Division name Department of Anesthesiology
Zip code 1838561
Address Musashidai 2-8-29, Fuchu, Tokyo
TEL 0423005111
Homepage URL
Email satomako1001@gmail.com

Sponsor
Institute Tokyo Metropolitan Children Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Metropolitan Children Medical Center
Address Musashidai 2-8-29, Fuchu, Tokyo
Tel 0423005111
Email satomako1001@gmail.com

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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 30 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043489

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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