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.: PACTR202203673199781 Date of Approval: 30/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between ultrasound-guided transversalis fascia and quadratus lumborum pane block for postoperative analgesia after inguinal herniotomy in children: a randomized controlled non-inferiority study
Official scientific title Comparison between ultrasound-guided transversalis fascia and quadratus lumborum pane block for postoperative analgesia after inguinal herniotomy in children: a randomized controlled non-inferiority study
Brief summary describing the background and objectives of the trial Transversalis fascia plane (TFP) block is a peripheral ultrasound-guided nerve block in which the local anesthetic is instilled between transversus abdominis muscle and its enclosing transversalis fascia at the level of the posterior axillary line targeting T12 and L1 nerves that convey the nociception from anterolateral abdominal wall [4]. The analgesic efficacy of TFP block has been demonstrated in adults' surgeries, including iliac crest bone graft harvesting [5], inguinal herniorrhaphy [6] and caesarean section [7,8]. In pediatric patients, TFP block provides effective postoperative analgesia after inguinal herniotomy in two children [9, 10]. The ultrasound-guided (USG) quadratus lumborum block was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle (QL) where Local anesthetics (LA) can be injected [11]. This technique provides analgesia after abdominal surgeries due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS) where lateral and anterior cutaneous branches from Th7 to L1 nerves can be blocked [12, 3]. This was proved later by Carney et al. [13] who found traces of contrast agent in the TPVS following the block. Our hypothesis is that transversalis fascia plane block will be non-inferior to quadratus lumborum block in providing postoperative analgesia in terms of analgesic consumption and pain severity after unilateral inguinal herniotomy in children. The aim of the study The aim of the study is to compare between transversalis fascia plane block and quadratus lumborum block regarding: - 1- The number and proportion of patients who will require rescue analgesia 2- The 12 h postoperative non-opioid analgesic requirements. 3 - The 12 h postoperative pain score. 4 - The incidence of postoperative no-surgical complications. 5- Parents' satisfaction. 6- Time consumed to perform the block.
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 Prevention
Anticipated trial start date 13/04/2022
Actual trial start date 20/04/2022
Anticipated date of last follow up 05/10/2022
Actual Last follow-up date 20/10/2022
Anticipated target sample size (number of participants) 80
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transversalis fascia block group 0.4 ml/kg bupivacaine 0.25% After induction of anesthesia ultrasound-guided transversalis fascia block will be performed unilaterally using the linear probe. 40
Control Group quadratus lumborum pane block 0.4 ml/kg bupivacaine 0.25% After induction of anesthesia The needle tip will be placed at the anterolateral border of the QL at its junction of QL with transversalis fascia, and the local anesthetic (0.4 ml/kg bupivacaine 0.25%) will be injected 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged between 12 to 60 months American Society of Anesthesiologists physical status I or II undergoing scheduled elective unilateral inguinal hernia repair previous inguinal surgery history of clinically significant cardiac, hepatic, renal, or neurological dysfunction coagulopathy known allergy to amide local anesthetics Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 12 Month(s) 60 Month(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 12/02/2022 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the number and proportion of patients who needed rescue analgesia during the first postoperative 12 hours. postoperative 12 hours
Secondary Outcome the postoperative FLACC pain score at 30 minutes in PACU and at 2, 4, 6, 9, 12 hours in ward, time to first rescue analgesia, opioid a non-opioid analgesic consumption during the first 12 postoperative hours, time consumed to perform the block and parent satisfaction that will be recognized as highly satisfied, just satisfied and not satisfied. first 12 postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Abdelbaser 2 Elgomhorria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 Elgomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Abdelbaser 2 Elgomhorria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.coom +201004976825 2 Elgomhorria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia faculty of medicine Mansoura university Egypt
Role Name Email Phone Street address
Public Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 Elgomhorria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia faculty of medicine Mansoura university Egypt
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 Elgomhorria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia faculty of medicine Mansoura university Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
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