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.: PACTR202204772010591 Date of Approval: 28/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound guided quadratus lumborum block in cirrhotic patients undergoing major abdominal surgery
Official scientific title Ultrasound guided quadratus lumborum block in cirrhotic patients undergoing major abdominal surgery (Randomized control trial)
Brief summary describing the background and objectives of the trial The quadratus lumborum block (QLB) a regional block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal ,gyn.&obs.&orthopedic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) QLB
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date 01/09/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL in international anasthesia journal
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control QLB 7ml of 0.9 normal saline befor start of surgery 0.9 normal saline the space between QL & thoracolumbar fascia, after negative aspiration then continuous infusion op bupivacaine0.25% at dose 0.1 mg/kg/h ,then the procedure repeated in the other side .7 Group S was injected with equal volume up 0.9 saline in the same plane. The patients in both groups do not know which injection will 30 Placebo
Experimental Group B QLB 0.3 mg/kg bupivacaine 0.25% Befor surgery 0.3 mg/kg bupivacaine 0.25%in the same plane after negative aspiration then continuous infusion op bupivacaine0.25% at dose 0.1 mg/kg/h ,then the procedure repeated in the other side 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients with hepatitis C (Child A &early B) Planned for major abdominal surgery 2. American Society of Anesthesiologists (ASAII–III ) 3. patients aged between 20 and 70 years 1. Previous history of preoperative opioid use. 2. Body mass index (BMI) > 35. 3. Allergy to local anesthetics. 4. Patients with coagulapathy 5. Contraindication to major surgery : • The presence of any systemic infection. • Uncontrolled systemic hypertention or diabetes mellitus Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 01/01/2021 institution review board national liver institute
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar sheben elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • To evaluate the effect of quadratus lumborum block on intra operative anesthetic consumption during surgery
Secondary Outcome • Effect of QLB on post operative pain & haemodynamics post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shibeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar shebeen elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor nationsl liver institute yassen abdelghfar sheben elkom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
wessam sultan yassen abdelghafar shebeen elkoom 23456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zainab fathy zainabfathy93@gmail.com 00201001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
sheben elkom Egypt rasident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 00201001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
sheben elkom Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries zainab fathy zainabfathy93@gmail.com 00201001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
sheben elkom Egypt resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. effect of QLB on pain manegement and patient haemodynamics Study Protocol when the result willbe available study protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia journal 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