Trial no.:	PACTR202204901612169	Date of Approval:	01/04/2022
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Ultrasound-guided Mid-Transverse Process to Pleural Block versus Thoracic paravertebral block in pediatric open-heart surgery: a randomized controlled non-inferiority study.

Official scientific title

Ultrasound-guided Mid-Transverse Process to Pleural Block versus Thoracic paravertebral block in pediatric open-heart surgery: a randomized controlled non-inferiority study.

Brief summary describing the background and objectives of the trial

The aim of the study is to compare between patients who will receive a single shot ultrasound-guided bilateral MTPB and patients who will receive a single shot ultrasound-guided bilateral Thoracic paravertebral block (TPVB) regarding Analgesic effects on hemodynamic responses to sternotomy, the 24 h postoperative opioid analgesic requirements, time to first rescue analgesia and the 24 h postoperative pain score.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,Cardiology,Paediatrics,Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

01/05/2022

Actual trial start date

Anticipated date of last follow up

01/02/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Ultrasound guided Thoracic paravertebral block	bupivacaine 0.4mL/kg on each side	After induction	After the induction of anesthesia, the patient will be placed in a prone position with a pillow under the chest to perform the paravertebral block or the midpoint transverse process to pleural block on both sides. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound-guided TPVB and MTPB will be done under complete sterilization by using Sterillium®, sterile drapes, and putting the ultrasound probe in a sterile sheath. Ultrasound high frequency linear transducer of a GE Vivid S5 ultrasonography (General Electric Ving Med Systems, Horten, Norway) will be placed in a parasagittal position just lateral to the spinous processes of thoracic vertebra target of the paravertebral cavity. The procedure will be conducted on both sides of the spine. The internal intercostal membrane, which is continuous with the superior costotransverse ligament, will be generally observed as a thin radio-opaque line extending from the transverse process, creating a wedge-shaped pocket representing the thoracic paravertebral space. A 50 mm 22-gauge sonographic needle (stimuplex®; B. Braun Medical, Bethlehem, Pa) will inserted in an in-plane technique from a cephalad to a caudal direction and will be advanced.In TPVB group: Correct positioning of the needle will be confirmed by anterior displacement of the pleura upon the injection of the small bolus of saline or a local anesthetic. Once confirmed, when the needle pierced the internal intercostal membrane, and after careful aspiration to demonstrate the absence of air or blood, we will inject 0.25% bupivacaine 0.4mL/kg on each side.	30	Active-Treatment of Control Group
Experimental Group	Ultrasound guided Midpoint transverse process to pleura block	bupivacaine 0.4mL/kg on each side	bupivacaine 0.4mL/kg on each side	After the induction of anesthesia, the patient will be placed in a prone position with a pillow under the chest to perform the paravertebral block or the midpoint transverse process to pleural block on both sides. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound-guided TPVB and MTPB will be done under complete sterilization by using Sterillium®, sterile drapes, and putting the ultrasound probe in a sterile sheath. Ultrasound high frequency linear transducer of a GE Vivid S5 ultrasonography (General Electric Ving Med Systems, Horten, Norway) will be placed in a parasagittal position just lateral to the spinous processes of thoracic vertebra target of the paravertebral cavity. The procedure will be conducted on both sides of the spine. The internal intercostal membrane, which is continuous with the superior costotransverse ligament, will be generally observed as a thin radio-opaque line extending from the transverse process, creating a wedge-shaped pocket representing the thoracic paravertebral space. A 50 mm 22-gauge sonographic needle (stimuplex®; B. Braun Medical, Bethlehem, Pa) will inserted in an in-plane technique from a cephalad to a caudal direction and will be advanced.In the MTPB group: When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, we will inject 0.25% bupivacaine 0.4mL/kg on each side	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1- Children aged between 2 to 12 years 2- American Society of Anesthesiologists physical status Ⅰ& Ⅱ 3- Elective open cardiac surgery via median sternotomy	1- Repeated cardiac surgery 2- Emergency surgery 3- Intubated patients 4- Bleeding disorders	Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year	2 Year(s)	12 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

24/03/2022

Mansoura Faculty of Medicine Institutional Review Board

Ethics Committee Address
Street address	City	Postal code	Country
2 El-Gomhouria Street	Mansoura	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Heart rate (HR) and mean arterial pressure (MAP) before and after induction of anesthesia, after skin incision, after sternotomy, 15 minutes after CPB and after the closure of sternum.The total dose of fentanyl consumption in the first postoperative 24 hours.	Intraoperative and postoperative 24 hours
Secondary Outcome	1- Postoperative pain score at rest, that was assessed by modified objective pain discomfort score (MOPDS).in children at 1, 2, 6, 12, 18 and 24 hours after extubation. Fentanyl 1μg/kg will be given as a rescue analgesic when MOPS greater than 3 at rest. 2- The total dose of fentanyl consumption in the first postoperative 24 hours. 3- Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery. 4- Aortic cross clamping time (min) starting from the application of the clamp to aorta till its removal after completing the surgical repair. 5- CPB time and duration of surgery. 6- Time to first rescue analgesia. 7- Intensive care unit (ICU) length of stay.	Intraoperative and 24h postoperative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Mansoura university children hospital	2 El-Gomhouria Street	Mansoura	35516	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
ahmed refaat abourezk	2 El-Gomhouria Street	Mansoura	35516	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansoura university children hospital	2 El-Gomhouria Street	Mansoura	35516	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
Ahmed Refaat abouRezk	2 El-Gomhouria Street	Mansoura	35516	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	ahmed refaat abourezk	ahmed.refaat.rezk@gmail.com	201096958793	2 El-Gomhouria Street
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	assistant lecturer of anesthesia faculty of medicine Mansoura university Egypt.
Role	Name	Email	Phone	Street address
Public Enquiries	Ibrahim Abdelbaser	ibrahimbaser2010@yahoo.com	+201004976825	2 El-Gomhouria Street
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	Assistant professor of anesthesia faculty of medicine Mansoura university Egypt.
Role	Name	Email	Phone	Street address
Public Enquiries	Aboelnour Badran	dctr.dare2015@gmail.com	201096958793	Badran
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	professor of anesthesia faculty of medicine Mansoura university Egypt.
Role	Name	Email	Phone	Street address
Scientific Enquiries	ahmed refaat abourezk	ahmed.refaat.rezk@gmail.com	+201096958793	2 El-Gomhouria Street
City	Postal code	Country	Position/Affiliation
mansoura	35516	Egypt	assistant lecturer of anesthesia faculty of medicine Mansoura university Egypt.

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	We will individual participate data and share it through the PubMed indexed journal	Informed Consent Form,Study Protocol	Study Protocol Beginning 6 months and ending 12 months following article publication	We will individual participate data and share it through the PubMed indexed journal
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry