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.: PACTR202110586403919 Date of Approval: 04/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Para Umbilical Hernia Repair
Official scientific title Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Para Umbilical Hernia Repair
Brief summary describing the background and objectives of the trial Postoperative pain after abdominal surgeries is one of the most common complain that patient experienced. As effective constituents of multimode analgesia, quadratus lumborum block and transversus abdominis plan block are used for postoperative pain control. In this study our aim is to compare between the analgesic effect of ultrasound guided quadratus lumborum block versus transversus abdominis plane block in patients undergoing para umbilical 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 Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block
Anticipated trial start date 25/10/2020
Actual trial start date 29/10/2020
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 20/12/2021
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
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 Ultrasound Guided Quadratus Lumborum Block 0.2 mL/kg of 0.25% bupivacaine Per side and toxic thresholds are not exceeded. After the end of operation and before the start of the extubation, the block will be performed. The patient will be positioned supine with lateral tilt to perform the block, and the transducer will be placed at the level of the anterior superior iliac spine and will be moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed postero laterally until its posterior border will be visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied. Operator will need to adjust dosage to ensure toxic thresholds are not exceeded. 23
Control Group Ultrasound Guided Transversus Abdominis Plane Block 0.2 mL/kg of 0.25% bupivacaine per side And toxic thresholds not be exceeded After the end of operation and before the start of the extubation, the block technique will be performed The probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In plan technique will be used and the tip of the needle will be inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), (0.2 mL/kg of 0.25% bupivacaine per side) will be injected and toxic threshold will not be exceeded 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult, aged 20 - 60 years. 2. American Society of Anesthesiologists (ASA) Physical Status Class-I and II. 3. Scheduled for umbilical or para umbilical hernia repair 4. Under general anesthesia 1. Declining to give written informed consent. 2. History of allergy to the medications used in the study. 3. Contraindications to regional anesthesia (including coagulopathy and local infection). 4. Severe hepatic impairment (serum protein < 3g % and serum bilirubin > 3mg %). 5. Renal dysfunction (as determined by creatinine levels greater than 2 mg/dL or predicted creatinine clearance (CLcr) <50 ml/min. 6. Psychiatric disorder. 7. Pregnancy. 8. Morbid obesity (BMI: >40kg/m2) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 21/10/2020 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The visual analogue score and vital signs heart rate, systolic blood pr, diastolic blood pr, mean blood pr At PACU 30 mins after operation and then 2hrs, 4 hrs, 8 hrs, 12 hrs, 24 hr postoperatively
Secondary Outcome amount of rescue analgesia pethidine in mg that given intravenous when VAS is >3 and or when HR is >110 beats/min and /or MBP is >20% from the baseline Within 24 hr after operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 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 Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tarek Yahia Abd Elmoniem Moustafa 18 El Gahez street, nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Tarek Yahia Tarekyahiakottor90@gmail.com +201221587385 18 El Gahez street Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hatem Saeed Abdel Hamid Hatemsabdelhamid@gmail.com +201022068269 79 mohey eldin abdelhamid naser city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Engy Sami Atia Engy.sami1@yahoo.com +201276404274 Masr el gededa
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Statistical Analysis Plan Following publication Any purpose
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