Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000038998
Ethics application status
Approved
Date submitted
24/11/2019
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Erector Spinae Plane Block and Caudal block in pediatric patients
Scientific title
Comparison of ultrasound-guided Erector Spinae Plane Block and ultrasound-guided Caudal block in pediatric patients undergoing lower abdominal surgery
Secondary ID [1] 299709 0
None
Universal Trial Number (UTN)
U1111-1242-9782
Trial acronym
ESPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower abdominal surgery 315315 0
Condition category
Condition code
Anaesthesiology 313617 313617 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The age,ASA score,weight and sexity of patients will be recorded on the date of surgery. The patients will be divided into two groupes by close develop method before surgery. For the first group the Erector Spinae Plane Block will be applied with 0,5 ml/kg 0,25 % bupivacain at L1 vertebral region by ultrasound guidance.
After induction of anesthesia Laringeal Mask Airway (LMA) will be inserted or the patient will be entubated. Following induction the patient will remove to lateral position. Under sterile conditions the Erector Spine Muscle and the transvers process of L1 vertebra will be showed by ultrasound.The needle will be advanced deep to the Erector Spine Muscle and the local anesthetic will be injected by the guidance of ultrasound.
For the second group the caudal block will be applied with maximum 2 mg/kg bupivacain in the volume of 1 ml/kg by ultrasound guidance. After induction of anesthesia Laringeal Mask Airway (LMA) will be inserted or the patient will be entubated. Following induction the patient will remove to lateral position. The ultrasound transducer will be first placed transversely at the midline to obtain the transverse sonographic view of the sacral hiatus. Under this transverse view the cornua of the sacrum, the sacrococcygeal ligament, and the sacral hiatus will be observed.Then, the transducer is rotated 90 degrees to rest between the two cornua and to obtain the longitudinal sonographic view of the sacral hiatus. The caudal needle will be advanced into the caudal epidural space and local anesthesics will be injected by ultrasound guidance.
The ESP Block and the caudal block both will be applied by same anesthesiologist after induction of anesthesia and before surgical incision.
The FLACC score will be evaluated at postoperative 15. minutes in PACU and postoperative 1.,3.,6. hours in surgery ward and 24. hour by telephone. Acetaminophen 15 mg/kg iv will be
done as rescue analgesia on the surgery ward in case of FLACC scores be
tween 2 and 4. If FLACC scores>4 tramadol 1 mg/kg iv will be given as rescue analgesic.Parents will be informed about the pain evaluation and instructed to administer 15 mg/kg oral acetaminophen if FLACC scores will between 2 and 4, and 7 mg/kg oral ibuprofen in case of FLACC scores of 4 or more.
The total analgesics will be recorded. The satisfaction of parents will be evaluated.
Intervention code [1] 316164 0
Treatment: Other
Comparator / control treatment
For the first group the Erector Spinae Plane Block will be applied with 0,5 ml/kg 0,25 % bupivacain at L1 vertebral region by ultrasound guidance. For the second group the caudal block will be applied with maximum 2 mg/kg bupivacain in the volume of 1 ml/kg by ultrasound guidance.
Control group
Active

Outcomes
Primary outcome [1] 322064 0
The FLACC score evaluation
Timepoint [1] 322064 0
Postoperative 15. minutes
Secondary outcome [1] 377180 0
The total analgesic consumption as assessed by data linkage to medical records
Timepoint [1] 377180 0
postoperative 24. hours

Eligibility
Key inclusion criteria
1) Lower abdominal surgery
2) The age between 1-7 years
3) ASA I-II
Minimum age
1 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)ASA III-IV
2) The known alergy to bupivacain
3)The infection at the needle puncture area

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2020
Actual
Date of last participant enrolment
Anticipated
23/03/2020
Actual
Date of last data collection
Anticipated
24/03/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 22142 0
Turkey
State/province [1] 22142 0
Mugla

Funding & Sponsors
Funding source category [1] 304184 0
Hospital
Name [1] 304184 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 304184 0
Turkey
Primary sponsor type
Individual
Name
Ali Ihsan Uysal
Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country
Turkey
Secondary sponsor category [1] 304415 0
None
Name [1] 304415 0
Address [1] 304415 0
Country [1] 304415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304654 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 304654 0
Ethics committee country [1] 304654 0
Turkey
Date submitted for ethics approval [1] 304654 0
05/11/2019
Approval date [1] 304654 0
13/11/2019
Ethics approval number [1] 304654 0
Decision number IV-22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97738 0
Dr Ali Ihsan Uysal
Address 97738 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 97738 0
Turkey
Phone 97738 0
+905067020960
Fax 97738 0
Email 97738 0
[email protected]
Contact person for public queries
Name 97739 0
Ali Ihsan Uysal
Address 97739 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 97739 0
Turkey
Phone 97739 0
+905067020960
Fax 97739 0
Email 97739 0
[email protected]
Contact person for scientific queries
Name 97740 0
Ali Ihsan Uysal
Address 97740 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 97740 0
Turkey
Phone 97740 0
+905067020960
Fax 97740 0
Email 97740 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposa

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication on request and ending 1 year following publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The data can be obtained by emaling the principal investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.