UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2020 Year 12 Month 12 Day
Anticipated trial start date	2020 Year 02 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	2020 Year 03 Month 30 Day

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