UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038156 |
|---|---|
| Receipt number | 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 | 2020/03/30 12:03:46 |
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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
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
satomako1001@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043489
