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.: PACTR201807311514045 Date of Approval: 30/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title quadratus lumborum block versus ilioinguinal nerve block
Official scientific title Analgesic efficacy of ultrasound guided quadratus lumborum block versus ilioinguinal nerve block following pediatric open inguinal hernia repair
Brief summary describing the background and objectives of the trial Ultrasound guided ilioinguinal (hypogastric) nerve block is a commonly used and effective postoperative analgesic technique for inguinal surgery. It classically involves blockade of the ilioinguinal and iliohypogastric nerve terminations of the 1st lumbar nerve root of the lumbar plexus anteromedial to the anterior superior iliac spine (ASIS). 1 The technique presents two challenges. First, the muscles of the abdominal wall (external and internal oblique, transversus abdominis) can be difficult to image, and many operators experience difficulty with local anesthetic placement using the out-of-plane technique at this location. 2 The Transversus Abdominis Plane (TAP) block has been used for postoperative analgesia for abdominal and pelvic surgical procedures. Nevertheless, the anterior approach to the TAP block has shown limited analgesic effect due to its short duration (up to 10 h) and mostly parietal pain relief profile.3,4 The posterior approach, or quadratus lumborum (QL) block, first described in 2007 by Blanco, demonstrated a spread to the paravertebral space, thus leading to a more extensive and long lasting block, with the potential to provide visceral pain relief.5 The aim of the current study is to compare the analgesic efficacy of ultrasound guided quadratus lumborum block versus ilioinguinal nerve block in pediatric patients undergoing open inguinal hernia repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2018
Actual trial start date 04/09/2018
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date 26/04/2020
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
32214 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
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
Experimental Group Quadratus lumborum block 0.3 ml/kg of bupivacaine 0.25%. The total dose of bupivacaine would not exceed2 mg/kg single shot ultrasound guided Quadratus lumborum (QL) block after induction of general anesthesia. 30
Experimental Group Ilioinguinal iliohypogastric nerve block 0.3 ml/kg of bupivacaine 0.25%. The total dose of bupivacaine would not exceed2 mg/kg single shot ultrasound guided Ilioinguinal (iliohypogastric) nerve block after induction of general anesthesia. 30
Control Group control whole study time general anesthesia only 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 1-8 years either gender ASA I-II undergoing elective unilateral open inguinal hernia repair Regional block refusal surgical scar or distorted anatomy at the site of injection known hypersensitivity to relevant drugs Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 8 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 01/03/2018 Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CHEOPS scale immediately after transfer to PACU, at 1h, 2h, 4h, 6h, 12h, 18h and 24 h.
Secondary Outcome 24 h postoperative rescue analgesic consumption once after 24 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Algeish street Tanta 31511 Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Algeish street Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed Mohye Eldin 55 Stad street Tanta 31511 Egypt
Shaimaa Farouk Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201099707168 stad street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com +201270440771 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Tanta University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com +201099707168 Stad street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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