Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012908116850 Date of Approval: 03/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided serratus anterior plane block versus paravertebral block for postoperative analgesia in children undergoing thoracoscopic surgeries
Official scientific title Ultrasound guided serratus anterior plane block versus paravertebral block for postoperative analgesia in children undergoing thoracoscopic surgeries
Brief summary describing the background and objectives of the trial The aim of this prospective double blinded controlled randomized study is to compare the postoperative analgesic efficacy of serratus anterior plane (SAP) block versus thoracic paravertebral block on postoperative pain score and analgesic requirements in children undergoing thoracoscopic surgeries. Sixty patients will be recruited and randomly allocated to 2 equal groups:- PV block group: patients will receive USG thoracic paravertebral 0.4 ml/kg 0.25 bupivacaine injectate in thoracic paravertebral space. SAP block Group: patients will receive with 0.4 ml/kg 0.25 mg/kg bupivacaine injectate in serratus anterior plane. The primary outcome measure is the total morphine consumption in the first postoperative 24 h. The secondary outcome measures are postoperative pain score, time to first rescue analgesia and its frequency, parents satisfaction and block related complications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2020
Actual trial start date 23/12/2020
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group patients will receive USG thoracic paravertebral 0.4 ml/kg 0.25 bupivacaine After induction of anesthesia The patient will be placed in the lateral or prone position following hemodynamic stability. Following skin preparation, a high-frequency linear ultrasound transducer will be placed in the transverse process of 5th thoracic vertebra. The US probe is then moved medially from there to reach the paravertebral space, which is at the level of the transverse processes where the upper surface is flat and intercostal muscles disappear. Superior costotransverse ligament (CTL) may be seen as a hyper‑echoic line between the two transverse processes with the pleura underneath it. In‑plane approaches can be taken to inject a volume of 0.4 ml/kg of bupivacaine 0.125% and fentanyl 2ug/ml between the CTL and the pleura. Upon injection of LA, pleura will be seen moving down, which is a hallmark of correct needle placement. 30 Active-Treatment of Control Group
Experimental Group Ultrasound guided serratus anterior plane block 0.4 ml/kg 0.25 mg/kg bupivacaine After induction of anesthesia The probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. We will count the ribs inferiorly and laterally, until we identify the 5th rib in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major (superior) and serratus anterior muscles (deep and inferior) will then easily identifiable by ultrasound overlying the fifth rib. As an extra reference point, we use the thoracodorsal artery; this aids in the identification of the plane superficial to the serratus muscle. After aseptic preparation of the skin and probe, the needle (short beveled) will be introduced in plane with respect to the ultrasound probe from supero-anterior to postero-inferior. To prevent inadvertent pneumothorax, it is important to aim the needle towards the rib [1]. Under continuous ultrasound guidance, we will inject a mixture of 0.4 ml/kg bupivacaine 0.125% and fentanyl 2ug/ml. half the volume will be injected superficial to the serratus anterior muscle and the other half underneath the muscle. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of either sex. Age ranging from 1 to 10 years. Undergoing thoracoscopy surgeries. History of clinically significant cardiac, hepatic, renal, or neurological conditions. Known allergy to local anesthetics. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 10 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 31/10/2020 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
2- Elgomhorria St. Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is the total morphine consumption in the first postoperative 24 h. First postoperative 24 h.
Secondary Outcome The secondary outcome measures are:- 1. Postoperative pain score. 2. Time to first rescue analgesia and its frequency. 3. Parents satisfaction. 4. Block related complications (pneumothorax, local anesthetic toxicity or hematoma). 5. Nausea and vomiting first postoperative 24 h.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 EL Gomhouria st. Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 EL Gomhouria st. Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital MUCH 2 EL Gomhouria st. Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 EL Gomhouria st. Mansoura 35516 Egypt
Sayed Emam 2 EL Gomhouria st Mansoura 35516 Egypt
May ElSherbiny Hafez 2 EL Gomhouria st Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 EL Gomhouria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Elsayed Elemam sayedemam0606@gmail.com +201008765995 2 EL Gomhouria st.
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries May Elshirbiny mayelsherbiny7@gmail.com +20100719359 2 EL Gomhouria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper Informed Consent Form,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request ibrahimbaser2010@yahoo.com
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