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.: PACTR202001664130773 Date of Approval: 14/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Femoral and Sciatic Nerve Blocks versus Caudal Block for Lower Limb Surgeries in Paediatrics
Official scientific title Ultrasound Guided Femoral and Sciatic Nerve Blocks versus Caudal Block for Lower Limb Surgeries in Paediatrics
Brief summary describing the background and objectives of the trial Introduction: Regional analgesia/anaesthesia is a safe and effective method in providing adequate perioperative pain control in paediatrics, it is usually performed in anaesthetized or deeply sedated children.(1) Regional techniques reduce postoperative morbidity, provide early mobilization and discharge, and reduce perioperative opioid analgesics requirements.(2) Recently, there is a trend to do regional analgesia/anaesthesia away from the central neuraxial blocks towards peripheral nerve blocks. Point-of-care ultrasound is being used for regional anaesthesia in paediatrics, providing shorter time for block performance, higher success rates, rapid onset, longer duration, less side effects, and reduction in volume of local anaesthetic agents required.(3) Aim of the study: This study aims to evaluate the efficacy of ultrasound guided femoral and sciatic nerve blocks versus caudal block for unilateral lower limb surgeries in paediatrics. The primary aim is postoperative analgesia. While, the secondary aim is to record total amount of rescue analgesic consumption (nalbuphine), frequency of nalbuphine administration, parents’ satisfaction, and complications of the regional technique provided.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2018
Actual trial start date
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group C ultrasound guided caudal analgesia 1ml/kg of 0.25 % levobupivacaine, a maximum volume of 20 ml 20 min children will receive ultrasound guided caudal analgesia after GA. Caudal block will be performed by visualizing the sacral hiatus at the level of the sacral cornus after placing a linear high frequency probe (7-13 MHz) transversely obtaining a short axis view, 2 hyperechoic lines will appear between the sacral cornus, the superficial line is the sacrococcygeal ligament which will be pierced by the needle using the out-of-plane approach. After confirming the absence of any blood or cerebrospinal fluid in the aspiration, the caudal mixture (1ml/kg of 0.25 % levobupivacaine, a maximum volume of 20 ml will be used) will be injected. 50
Control Group Group P peripheral nerve blocks 0.3 ml/kg of 0.25 % levobupivacaine 20mi children will receive lower limb peripheral nerve blocks in the form of (femoral nerve block plus subgluteal sciatic nerve block). For femoral nerve block. the child will be positioned supine, a high frequency linear probe (7-13 MHz) will be put on the inguinal crease transversely to identify the femoral nerve, artery, and vein. The femoral nerve is identified lateral to the artery and the femoral vein is seen medial to the artery. An in-plane approach will be used, the needle will be introduced from lateral to medial towards the femoral nerve and the local anaesthetic (0.3 ml/kg of 0.25 % levobupivacaine) will be injected circumferentially around the nerve.(4) For sciatic nerve block, the subgluteal approach to the sciatic nerve will be used. The child will be positioned in the lateral decubitus position. The ultrasound high frequency probe (7-13 MHz) will be placed at the gluteal crease between the greater trochanter and the ischial tuberosity, the gluteus maximus muscle is identified; the sciatic nerve is situated deep to this muscle. An in-plane approach will be used for needle guidance. The local anaesthetic (0.3 ml/kg of 0.25 % levobupivacaine) will be injected surrounding the nerve 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 1-12 years American Society of Anesthesiologists (ASA) physical status I or II Scheduled for lower limb surgeries The lack of parental consent Allergy to local anaesthetics Preexisting neuropathy (with sensory and/or motor deficits), Cutaneous infection Wound close to the puncture point Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 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 18/10/2018 Ethical committee Faculty of Medicine. Alexandria University
Ethics Committee Address
Street address City Postal code Country
Khartoum square Alexandri 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative analgesia every 2 h for 8 h and every 4 h thereafter until 24 h
Secondary Outcome record total amount of rescue analgesic consumption (nalbuphine), frequency of nalbuphine administration, parents’ satisfaction, and complications of the regional technique provided every 2 h for 8 h and every 4 h thereafter until 24 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospitals Khartoum square, Azaria Alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rabab Mahrous 33 Bahaa ElDin Elghatwary Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabab mahrous 33 Bahaa eldin Elghatwary Alexandria 21526 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rabab Mahrous 33 Bahaa ElDin Elgharwary, Smouha Alexandria 21526 Egypt
Amin Ahmed 33 Babaa Eldin Elghatwar, Smouha Alexandria Egypt
Aly Mahmoud Mostafa Antoniades compound Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Mahrous roba98@hotmail.com 00201223497339 33 Bahaa eldin Elghatwary
City Postal code Country Position/Affiliation
alexandria 21526 Egypt Assistant professor of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Amin Ahmed aminrazek@yahoo.com 1227392464 33 Bahaa eldin Elghatwary
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Aly Mostafa medical_all4one@hotmail.com 00201224129850 Antoniades Compound
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Clinical Study Report 1 year open access
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