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.: PACTR202305838359772 Date of Approval: 18/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound-guided anterior Quadratus Lumborum Block for postoperative pain after laparoscopic bariatric surgery
Official scientific title Ultrasound-guided anterior Quadratus Lumborum Block for postoperative pain after laparoscopic bariatric surgery
Brief summary describing the background and objectives of the trial Pain associated with laparoscopic surgery is multifactorial, including visceral, incisional, and referred pain components. Visceral pain is a complex condition that can be caused by mechanical traction, dilation, spasm, inflammation, ischemia, and chemical stimulation Recent regional techniques have been developed to address visceral pain while avoiding the potential complications associated with neuraxial techniques such as bleeding, infection, and spinal cord injury. The objective of this study is to determine the effect of pre-emptive quadratus lumborum block on intra- and postoperative pain control and opioid requirements in laparoscopic bariatric procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2023
Actual trial start date 01/02/2023
Anticipated date of last follow up 01/07/2023
Actual Last follow-up date 01/07/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Active, not 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Quadratus lumborum block 0.25% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) 0.2 ml/kg (according to lean body weight) will be injected on each side with care not to exceed the maximum safe dose. 24 hour After induction of anaesthesia, a quadratus lumborum block (QLB) will be performed using an ultrasound machine (Sonosite EDGE Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5–8-MHz curved probe will be used with the patient in the supine position. The QLB3 technique is adopted due to its convenience for the anaesthetist and the assisting staff. After sterilizing the abdomen with povidone-iodine solution, the probe will be placed at the level of the anterior superior iliac spine and directed cranially until the three abdominal muscles are clearly identified. The external oblique muscle will be followed postero-laterally until its posterior border is visualized with the underlying internal oblique forming a roof over the quadratus lumborum muscle. The probe will be tilted down to identify the bright hyperechoic line representing the intermediate layer of the thoracolumbar fascia. The needle (Sonoplex stim cannula, Pajunk, 21gauge × 100 mm, Nor Cross, Georgia, USA) will be inserted in plane from medial (anterior) to lateral (posterior). The optimal point of injection is determined by the hydrodissection 15
Control Group placebo 0.2 ml/kg of normal saline will be injected on each side 24 hour the same as expermintal group but normal saline is injected . 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
laparoscopic bariatric surgery (laparoscopic sleeve gastrectomy or gastric bypass) ASA III BMI ≥ 35 kg/m2 with comorbidity or ≥ 40 kg/m2 without comorbidity patients diagnosed with obstructive sleep apnea Pickwickian syndrome, coagulation defects hypersensitivity to bupivacaine contraindication to the use of NSAIDS sepsis at the site of injection or conversion to laparotomy. Adult: 19 Year-44 Year 18 Year(s) 50 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 17/03/2022 faculty of medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, El Messalah alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intra- and postoperative pain control and opioid requirements in laparoscopic bariatric procedures. intraoperative and first 24 hour
Secondary Outcome side effects such as nausea and decreased bowel motility. 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
madina hospital kamal eldeen streat alexandria 21648 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principle investigator moharam beh alexandria 21547 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor madina hospital kamal eldeen street alexandria 21648 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Yasser Essam Elfeil 5 Alomaraa Moharam beh Alexandria 21547 Egypt
Ehsan Akram Deghidy 5 Elomraa street Moharam Beh Alexandria 21547 Egypt
Adel ibrahim Hassan Hozain 165 Elhoryea Elhadara Alexandria 21561 Egypt
Hatem Baghat Ahmed Abo Elafa 370 El Horreya Avenue Moustafa Kamel Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasser elfeil dryasser.elfeil.ye@gmail.com 00201002708808 moharam beh
City Postal code Country Position/Affiliation
alexandria 00400 Egypt lecturer of anesthesia faculty of medicine
Role Name Email Phone Street address
Public Enquiries ehsan deghidy drehsan.deghidy@yahoo.com 00201063199658 Moharram beh
City Postal code Country Position/Affiliation
alexandria 00400 Egypt lecturer of Biomedical Informatics and Medical Statistics
Role Name Email Phone Street address
Scientific Enquiries Hatem Wafa hatem_wafa@hotmail.com 00201155497711 sidigaber
City Postal code Country Position/Affiliation
alexandria 00400 Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification with Study Protocol, Statistical Analysis Plan, and Informed Consent form will be available for any one for any purpose within one year on my google drive link (dryasser.elfeil.ye@gmail.com) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 1 year data will be available for all
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