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.: PACTR202107792304574 Date of Approval: 13/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ultrasound guided ilioingunial/ iliohypogastric nerve block versus transverse abdominis plane block in patients undergoing oblique inguinal hernia repair
Official scientific title A comparative study between ultrasound guided ilioingunial/ iliohypogastric nerve block versus transverse abdominis plane block in patients undergoing oblique inguinal hernia repair
Brief summary describing the background and objectives of the trial Compare between ultrasound guided transversus abdominis plane block versus ilioingunial/iliohypogastric block for postoperative pain control and opioid consumption in patients undergoing inguinal hernia repair.
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 postoperative pain management
Anticipated trial start date 01/10/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 31/10/2020
Actual Last follow-up date 31/10/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group study group Levobupivacaine 0.5% 10ml (with maximal dose 2 mg /kg) Levobupivacaine 0.5% 10ml (with maximal dose 2 mg /kg) preoperative period with induction of anesthesia Ilioinguinal/ Iliohypogastric (ILI/IHG) group :The ultrasound linear probe (Sonosite,M Turbo-C,Bothell,WA,USA) was placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve was seen medial to the ilioinguinal nerve. The overlying skin was prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula was advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles. Levobupivacaine 0.5% 10ml (with maximal dose 2 mg /kg) was injected. 50
Control Group TAP block Levobupivacaine 0.5% 25ml (with maximal dose 2 mg /kg) preoperative or with induction of anesthesia The injection site was indefined between the aponeurosis of the internal oblique and transversus abdominis muscles. Levobupivacaine 0.5% 25ml (with maximal dose 2 mg /kg) was injected with intermittent aspiration and the correct placement of the needle was confirmed by expansion of the LA solution as a dark shadow between the aponeurosis of the internal abdominal oblique (which moved anteriorly) and the transversus abdominis muscles pushing the muscle deeper. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Physical Status: ASA (American society of Anesthesiologists) I – II patients. - Adult over 21years old. - Patient under the age of 21 years. - Infection at site of injection. - Psychiatric illness or uncooperative patient. - Coagulopathy, use of anticoagulants or antiplatelet therapy. - Allergy to local anesthetic drugs. - Failed sensory block after 30 minutes from completion of the procedure preoperatively. - Drug intake; chronic analgesic users, drug addicts and alcoholic patients Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 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 30/01/2019 Ain Shams University Faculty of medicine Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain will be assessed at rest by VAS presented as a100-mm horizontal line on which the patient's pain intensity will be graded from 0 (without pain) to 100 (intolerable pain) before discharge from the PACU, at 4,8,12 and 24 hours post-operative. preoperative, intraoperative and postoperative
Secondary Outcome 1-Demographic data for each patient will be recorded preoperatively. 2-Hemodynamic data; mean arterial blood pressure (MAP), heart rate (HR) will be recorded every 5 minutes in first 20 minutes then data will be recorded every 30 minutes till the end of the operation. 3-Peripheral oxygen saturation (Spo2) will be recorded before anesthesia and every 5 minutes. 4-Cumulative dose of morphine consumption in the PACU and during the first 24 hours post-operative will be recorded. 5-Incidence of urine retention and postoperative nausea and vomiting will be documented. preoperative, intraoperative and postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University abbassia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed elwany abbassia cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University Abbassia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sohair Abass Mohamed abbasia cairo 11591 Egypt
Amr Mohamed AbdEl Fattah abbasia cairo 11591 Egypt
Ghada Mohamed Samir abbasia cairo 11591 Egypt
Nasser Elsayed Elsayed abbasia cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed elwany elwanytop10@gmail.com 00201001866906 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries amr abdel Fattah dramr2001@gmail.com 00201001034225 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries nasser elsayed Nasser_el-said@med.asu.edu.eg 00201096756606 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/06/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/06/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information