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.: PACTR202111789904479 Date of Approval: 29/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study between quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing caesarean section
Official scientific title Comparative study between quadratus lumborum block versus transversus abdominis plane block for postoperative analgesia in patients undergoing caesarean section
Brief summary describing the background and objectives of the trial Caesarean delivery is the most commonly performed inpatient surgical procedure globally. Pain after caesarean delivery is moderate to severe if not adequately treated, and is a primary anaesthetic concern for patients. Transversus abdominis plane and quadratus lumborum blocks are fascial plane blocks that have the potential to improve analgesia following caesarean delivery. Although proponents of the quadratus lumborum block suggest that this technique may provide better analgesia compared with transversus abdominis plane block, there are limited data directly comparing these two techniques. We, therefore, performed a systematic review and network meta-analysis to compare transversus abdominis plane and quadratus lumborum block approaches regarding the potency of the postoperative analgesia .
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 Pain managment
Anticipated trial start date 19/11/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 21/11/2021
Actual Last follow-up date 01/01/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
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
Control Group General anaestheia plus bilateral transversus abdominis plane block 20 ml of 0.25 % bupivacaine Post caesarean delivery TAP group (control group ), 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 are identified (external oblique, internal oblique, and transverse abdominis muscles). In‑plane 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), 20 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side . 30 Active-Treatment of Control Group
Experimental Group Quadratus lumborum block 20 ml0.25% bupivacane Post caserean delivery In QL group (experimental group) , the patient will be positioned supine with lateral tilt to perform the block, and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles are clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border is 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 represented 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 and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied and the same technique will be performed on the other side 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of American Society of Anesthesiologists (ASA) physical status I to II of female patients , aged 18-45 years, scheduled for caesarean section under general anaesthesia Patients were excluded from the study if they showed infection at injection site, allergy to local anaesthetics, coagulation disorders, morbid obesity, physical or mental diseases which could interfere with the evaluation of pain scores Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
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 09/01/2021 Research Ethics Commitee at faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbasya,Cairo,Egypt Abbasya 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose of morphine used postoperatively (rescue analgesia) for 24 h 24 hours
Secondary Outcome VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative .
Secondary Outcome Duration of postoperative analgesia the time from recovery to the first given dose of morphine
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university El-Khalyfa El-Mamoun streetAbbasya,Cairo,Egypt Abbasya 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed atef mohammed Al-mokattam ,karim banona Cairo 11571 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed atef mohammed Al-mokattam,karim banona Cairo 11571 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ain shams university El-Khalyfa El-Mamoun Street Abbasya,cairo,Egypt Abbasya 11517 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Atef mohammed Ahmedatefhassan89@gmail.com 01025298880 Al-mokattam ,karim banona
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Atef mohammed Ahmedatefhassan89@gmail.com 01025298880 Al-mokattam ,karim banona
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Atef mohammed Ahmedatefhassan89@gmail.com 01025298880 Al-mokattam ,karim banona
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article,after deidentification Study Protocol Immediately following publication no end date Any one who wishes to access the data for any purpose data will be available indefinitly at https://asja.springeropen.com/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Https://asja.springeropen.com/ 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