Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000841279p
Ethics application status
Submitted, not yet approved
Date submitted
14/05/2018
Date registered
18/05/2018
Date last updated
18/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pediatric sonar guided Quadratus Lumborum block.
Scientific title
Ultrasound guided Quadratus Lumborum block in Pediatrics: Trans-muscular versus intra-muscular approach.
Secondary ID [1] 294883 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intraoperative pain 307839 0
postoperative pain 307858 0
Condition category
Condition code
Anaesthesiology 306882 306882 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In all patients, sonar guided QL block will be performed after induction of anesthesia and before start of surgery. The patients will be randomly classified into two groups according to the block approach. Group I include patients (20 patients) in whom QL block will be done using anterior approach (i.e. trans-muscular QL block).
Intervention code [1] 301197 0
Prevention
Comparator / control treatment
Group II (control group) include 20 patients in whom QL block will be done using sonar guided intramuscular approach after induction of anesthesia and before start of surgery.
Control group
Active

Outcomes
Primary outcome [1] 305873 0
The primary outcome measure will be the number of patients who need rescue analgesia. Postoperative pain level was assessed using FLACC (Face, Legs, Activity, Cry, Consolability) score. The score ranges from 0 to 10. The 0 score indicates no pain while 10 score indicates the most severe pain. Patients with FLACC score equal to 4 will receive tramadol 1 mg/kg IV.
Timepoint [1] 305873 0
in the first 24 hours at 2, 4, 6 12, 24 hours post-operatively.
Secondary outcome [1] 346861 0
The secondary outcome measure is pain score assessed by FLACC score.
Timepoint [1] 346861 0
at 2, 4, 6 12, 24 hours postoperatively
Secondary outcome [2] 346923 0
heart rate by monitoring device.
Timepoint [2] 346923 0
at 2, 4, 6 12, 24 hours postoperatively
Secondary outcome [3] 346924 0
non-invasive blood pressure by monitoring device philips intellvue MP50.
Timepoint [3] 346924 0
at 2, 4, 6 12, 24 hours postoperatively
Secondary outcome [4] 346925 0
postoperative complications (example: hematoma, allergic reaction) assessed by data linkage to medical records.
Timepoint [4] 346925 0
during first 24 hours postoperatively.

Eligibility
Key inclusion criteria
40 patients, age between 1 to 6 years old who will undergo elective lower abdominal surgery under general anesthesia will be enrolled in our study. Patients selected will be of both sexes with American Society of Anesthesiologists (ASA) physical status I/II.
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include coagulopathy, liver disease, local redness or infection at site of needle injection, known allergy to local anesthetics or parent refusal to participate in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using PASS11 program (SPSS Inc., Chicago, IL., USA), setting alpha error at 5% and power at 80%, result from previous study showed that among QL group, the percentage of children needed analgesia is as 12.5% compared to 41.6% among the second group. Based on this, the needed sample is 27 cases per group. (54 cases total)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2018
Actual
Date of last data collection
Anticipated
2/08/2018
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 10404 0
Egypt
State/province [1] 10404 0
Cairo

Funding & Sponsors
Funding source category [1] 299468 0
University
Name [1] 299468 0
Ain Shams university
Country [1] 299468 0
Egypt
Primary sponsor type
University
Name
Ain Shams university
Address
Ramses street, Abassia,Cairo, Egypt
Box office: 11566.
Country
Egypt
Secondary sponsor category [1] 298781 0
None
Name [1] 298781 0
Address [1] 298781 0
Country [1] 298781 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300375 0
ethics committe in faculty of medicine, Ain shams university.
Ethics committee address [1] 300375 0
Ramses street, Abassia, Cairo, Egypt
Box office:11566
Ethics committee country [1] 300375 0
Egypt
Date submitted for ethics approval [1] 300375 0
01/03/2018
Approval date [1] 300375 0
Ethics approval number [1] 300375 0

Summary
Brief summary
Ultrasound-guided quadratus lumborum block (QL) is considered now as one of the new truncal abdominal block as it is effective in preventing somatic pain associated with upper and lower abdominal surgeries. In all patients, sonar guided QL block will be performed after induction of anesthesia and before start of surgery. The patients will be randomly classified into two groups according to the block approach using a computer-generated table. Group I include patients (20 patients) in whom QL block will be done using anterior approach (i.e. trans-muscular QL block). Group II include patients (20 patients) in whom QL block will be done using intramuscular approach. Surgery will be started 10 minutes after performing the block. Any complications occurring during surgery will be recorded carefully. All patients will receive paracetamol 15 mg/kg at the end of the surgery.

Postoperative pain level will be assessed using FLACC score. The score ranges from 0 to 10. The 0 score indicates no pain while 10 score indicates the most severe pain. The postoperative pain score will be assessed at 2, 4, 6 12, 24 hours in the surgical ward by another anesthetist blinded to group allocation. Patients with FLACC score equal to 4 will receive tramadol 1 mg/kg IV. The primary outcome measure is the number of patients who need rescue analgesia in the first 24 hours. The secondary outcome measures are FLACC score, heart rate, non-invasive blood pressure at 2, 4, 6 12, 24 hours postoperatively and postoperative complications. Using PASS11 program (SPSS Inc., Chicago, IL., USA), setting alpha error at 5% and power at 80%, result from previous study showed that among QL group, the percentage of children needed analgesia is as 12.5% compared to 41.6% among the second group. Based on this, the needed sample is 27 cases per group. (54 cases total)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83454 0
Dr Mostafa Mansour Houssein
Address 83454 0
Faculty of medicine, Ain Shams university, Ramses street, Abassia, Cairo, Egypt
Box office: 11566
Country 83454 0
Egypt
Phone 83454 0
+201093322145
Fax 83454 0
Email 83454 0
[email protected]
Contact person for public queries
Name 83455 0
Dr Mostafa Mansour Houssein
Address 83455 0
Faculty of medicine, Ain Shams university, Ramses street, Abassia, Cairo, Egypt
Box office: 11566
Country 83455 0
Egypt
Phone 83455 0
+201093322145
Fax 83455 0
Email 83455 0
[email protected]
Contact person for scientific queries
Name 83456 0
Dr Mostafa Mansour Houssein
Address 83456 0
Faculty of medicine, Ain Shams university, Ramses street, Abassia, Cairo, Egypt
Box office: 11566
Country 83456 0
Egypt
Phone 83456 0
+201093322145
Fax 83456 0
Email 83456 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUltrasound-guided quadratus lumborum block in pediatrics: trans-muscular versus intra-muscular approach.2018https://dx.doi.org/10.1007/s00540-018-2563-z
N.B. These documents automatically identified may not have been verified by the study sponsor.