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.: PACTR202306798547641 Date of Approval: 19/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultra-sound guided rhomboid intercostal blockade versus thoracic paravertebral blockade in pediatric thoracoscopic sympathectomy
Official scientific title Ultra-sound guided rhomboid intercostal blockade versus thoracic paravertebral blockade in pediatric thoracoscopic sympathectomy
Brief summary describing the background and objectives of the trial Video-assisted thoracoscopic surgery (VATS) has been commonly used nowadays for its many advantages such as minimal invasiveness, marked reduction in post- operative pain, faster recovery rate and superior cosmetic results. Recently, the use of VATS in pediatric patients is increasing due to refinements in the technique, improvements in instrumentation, and advances in pediatric anesthesia . Thoracic paravertebral block (TPVB) is a classic block with definite analgesic effect for both somatic and visceral pain .Some authors believe that rhomboid intercostal block has same analgesic effect of other planes block. This prospective, randomized, double blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound guided thoracic paravertebral block with ultrasound guided rhomboid intercostal block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound guided rhomboid intercostal block may provide effective postoperative analgesia as ultrasound guided thoracic paravertebral block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/07/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 08/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Thoracic paravertebral block 0.4 ml/kg bupivacaine 0.25% that will be injected into thoracic paravertebral space. intraoperative before incision. Thoracic paravertebral block (n=35): Patients will receive 0.4 ml/kg bupivacaine 0.25% that will be injected into thoracic paravertebral space. 35 Active-Treatment of Control Group
Experimental Group Rhomboid intercostal block 0.4 ml/kg bupivacaine 0.25% intraoperative before incision Rhomboid intercostal block (n=35): Patients will receive 0.4 ml/kg bupivacaine 0.25% that will be injected on the upper intercostal muscles under the rhomboid major muscle. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists physical status I–II of either sex age ranging from 6 to 18 years undergoing thoracoscopic sympathectomy. refusal of their guardians, redo surgery, previous surgery which would preclude the performance of needle puncture, local infection of the skin and subcutaneous tissue at the site of needle puncture, hypersensitivity to local anesthetics coagulation disorders Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 18 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 18/05/2021 Mansoura Faculty ofMedicineInstitutional ReviewBoard
Ethics Committee Address
Street address City Postal code Country
2 elgomhouria street mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total dose of morphine requirements. 24h postoperative.
Secondary Outcome 1- Postoperative pain will be assessed using a modified Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) at 0, 1, 6, 12, 18, 24 hours after surgery. 24h postoperative
Secondary Outcome Heart rate [HR] and invasive mean arterial blood pressure [MAP] will be recorded before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, every 30 minutes and after skin closure. intraoperative
Secondary Outcome Time of first rescue analgesia. 24h postoperative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Alameer Abo Elftoh 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 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Alameer Abo Elftoh 2 El-Gomhouria Street Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Alameer Abo Elftoh midodwaik@gmail.com +201007048034 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura Egypt assistant lecturer of anesthesia facultyof medicine mansoura university
Role Name Email Phone Street address
Public Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-GomhouriaStreet
City Postal code Country Position/Affiliation
mansoura Egypt Assistant professor of anesthesia facultyof medicine Mansoura universityEgypt
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-GomhouriaStree
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor of anesthesia facultyof medicine Mansoura university Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant datathat underlie the results,after deidentification (text,tables, figures, andappendices) will be reported.We will individual participate data and shareit through thePubMed indexed journal. IPD that will be generated from this study will be shared upon request from theresearchers andpermission from theUniversity research andpublication director. Informed Consent Form Study Protocol Beginning 6months and ending 12months following article publication We will individualparticipatedata and share itthrough thePubMed indexedjournal
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