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.: PACTR202003482868387 Date of Approval: 24/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of ultrasound-guided erector spinae plane block and ilioinguinal-ilihypogastric block for postoperative analgesia in paediatric inguinal hernia repair
Official scientific title Comparison of ultrasound-guided erector spinae plane block and ilioinguinal-ilihypogastric block for postoperative analgesia in paediatric inguinal hernia repair: a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Erector spinae plane (ESP) block is a promising technique in the field of pediatric postoperative analgesia. We aim to assess whether ultrasound-guided ESP would provide comparable postoperative analgesia to ilioinguinal-iliohypogastric nerve block in pediatric unilateral inguinal hernia surgery.
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 Treatment: Drugs
Anticipated trial start date 01/04/2020
Actual trial start date
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector spinae plane block 0.5 ml/kg 0.25% bupivacaine Just after receiving general anesthesia for 24 h postoperatively With the patient in lateral decubitus position (side to puncture positioned at the top), the transverse processes of L2 vertebrae and erector spinae (ES) fascia are visualized in a parasagittal plane 1-2 cm from the posterior midline using a linear ultrasound probe. A 22G peripheral block needle is introduced with in-plane technique under the erector spinae muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP. 40
Control Group ilioinguinal iliohypogastric nerve block 0.5 ml/kg 0.25% bupivacaine Just after receiving general anesthesia and for 24 h postoperatively Following aseptic preparation of the skin and probe, the US probe was placed immediately medial and slightly cephalic to the upper aspect of the anterior superior iliac spine to get a short-axis view of the nerves situated between the internal oblique (IO) and transversus abdominis (TA) muscles. Using an in-plane technique, the needle was advanced till interface between the IO and TA muscle. under real-time visualization, we track the solution surrounding of the two hypoechoic ilioinguinal and iliohypogastric nerves. 42 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 6 mounths-12 years ASA physical status I-II elective inguinal hernia repair Allergy to local anesthetics, Unable to be assessed for pain score A history of delayed development Refusal to regional anesthesia Hemostais disorders Infection of the puncture area Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Month(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 18/07/2019 Comite d ethique
Ethics Committee Address
Street address City Postal code Country
IBN ROCHD avenue Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparison of postoperative age appropriate numerical pain score (Facial expression, Leg activity, Crying and Consolability scale or simple numerical rating score) at 2 h. 2h postoperative period
Secondary Outcome intraoperative sufentanil use, numerical pain score at various intervals in the first 24h and time to first postoperative supplementary analgesic dose, the total postoperative paracetamol consumption, the amount of rescue morphine use per weight, and parental satisfaction (0–10, 0 = very unsatisfied with the pain relief, 10 = very satisfied with the pain relief), and adverse effects such as nausea/vomiting Different intervals in the first 24h for pain score, parental satisfaction at discharge.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children Hospital of Rabat IBN ROCHD avenue Rabat Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Children Hospital of Rabat IBN ROCHD Avenue Rabat Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Children hospital of Rabat IBN ROCHD avenue Rabat 10100 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
Alae El Koraichi Ibn Rochd Avenue Rabat Morocco
abdelghafour Elkoundi Ibn Rochd Avenue Rabat Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelghafour Elkoundi abd.el.koundi@gmail.com +212661610104 IBN ROCHD avenue
City Postal code Country Position/Affiliation
Rabat Morocco Department of pediatric Anesthesia Children Hospital of Rabat
Role Name Email Phone Street address
Scientific Enquiries Abdelghafour Elkoundi abd.el.koundi@gmail.com +212661610104 IBN ROCHD avenue
City Postal code Country Position/Affiliation
Rabat Morocco Department of pediatric Anesthesia Children Hospital of Rabat
Role Name Email Phone Street address
Public Enquiries Abdelghafour Elkoundi abd.el.koundi@gmail.com +212661610104 IBN ROCHD avenue
City Postal code Country Position/Affiliation
Rabat Morocco Department of pediatric Anesthesia Children Hospital of Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study will be available from the Children Hospital of Rabat. Data will be available from the authors upon reasonable request after permission of the Children Hospital of Rabat. Results will be available within 12 months of the study completion date. Clinical Study Report,Study Protocol 3 months following publication. Ending 36 months following publication. Researchers who provide a methodologically sound proposal. For individual participant meta-analysis. Proposal should be directed to abd.el.koundi@gmail.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