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.: PACTR202303516170041 Date of Approval: 29/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative analgesic effects of various quadratus lumborum block approaches following major gynaecological surgery
Official scientific title Postoperative analgesic effects of various quadratus lumborum block approaches following major gynaecological surgery
Brief summary describing the background and objectives of the trial Pain in major gynaecological surgery is a combination of an inflammatory response, nerve injury, and tissue damage which involving the whole abdominal wall layers starting from the superficial layers to the deeper peritoneal layers with a variant intensity of nociceptive and neuropathic pain . Opioids can provide an efficient control of postoperative pain which are the analgesic of choice but have many dose-related side effects including nausea, vomiting, drowsiness, respiratory complications and delaying patient ambulation with an increase the risk of Deep Venous Thrombosis (DVT) The aim of this study is to observe the effects of two practical QLB approaches, including type 2 and 3, as well as combination of QLB (2+3) in relieving postoperative pain following gynecological surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied myomcectomy and hystrectomy
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2023
Actual trial start date 03/02/2023
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 QL2 group 0.25% levobupivacaine 30 mL on each side 48 hours QLB will be performed with atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks, B. Braun Melsungen AG, Germany) advanced in-plane under the guidance of an ultrasound machine (X-Porte, Sonosite Ltd, USA) with a convex probe (2–5 MHz). With the patient in the supine position. The ultrasonogram of the abdominal wall could be displayed clearly through probe moving or tilting after the skin preparation with 2% chlorhexidine. Pillows could help to relieve the tension along the abdominal wall of patients. The whole procedure will be performed strictly according to clinical protocol. In this study, QL2 will be conducted through an anterolateral approach with the supine position as mentioned earlier. The ultrasound transducer will be placed transversely on both flanks at the horizontal level of L2-3 and will be adjusted until the “Shamrock sign” formed of QL muscle, psoas major and erector spinae will be visualized, with imaging depth set between 0 and 9.9 cm .Needles will penetrate in an anterolateral to posteromedial direction. Local anesthetic will be injected posterior to QL muscle in QL2, . The solution will be injected after negative aspiration to exclude vascular puncture 20
Experimental Group QLB 3 0.25% levobupivacaine (AstraZeneca, Södertälje, Sweden) at 30 mL at the sites 48 hours QLB will be performed with atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks, B. Braun Melsungen AG, Germany) advanced in-plane under the guidance of an ultrasound machine (X-Porte, Sonosite Ltd, USA) with a convex probe (2–5 MHz). With the patient in the supine position. The ultrasonogram of the abdominal wall could be displayed clearly through probe moving or tilting after the skin preparation with 2% chlorhexidine. Pillows could help to relieve the tension along the abdominal wall of patients. The whole procedure will be performed strictly according to clinical protocol. In this study, QL3 will be conducted through an anterolateral approach with the supine position as mentioned earlier. The ultrasound transducer will be placed transversely on both flanks at the horizontal level of L2-3 and will be adjusted until the “Shamrock sign” formed of QL muscle, psoas major and erector spinae will be visualized, with imaging depth set between 0 and 9.9 cm .Needles will penetrate in an anterolateral to posteromedial direction. Local anesthetic will be injected between QL muscle and psoas major.The solution will be injected after negative aspiration to exclude vascular puncture 20
Experimental Group combined QLB 2 and 3 0.25% levobupivacaine 15 mL at each point of injection with the needle inserting only once in each side total 30 ml per side 48 hours QLB will be performed with atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks, B. Braun Melsungen AG, Germany) advanced in-plane under the guidance of an ultrasound machine (X-Porte, Sonosite Ltd, USA) with a convex probe (2–5 MHz). With the patient in the supine position. The ultrasonogram of the abdominal wall could be displayed clearly through probe moving or tilting after the skin preparation with 2% chlorhexidine. Pillows could help to relieve the tension along the abdominal wall of patients. The whole procedure will be performed strictly according to clinical protocol. In this study,QL2+3 will be conducted through an anterolateral approach with the supine position as mentioned earlier. The ultrasound transducer will be placed transversely on both flanks at the horizontal level of L2-3 and will be adjusted until the “Shamrock sign” formed of QL muscle, psoas major and erector spinae will be visualized, with imaging depth set between 0 and 9.9 cm .Needles will penetrate in an anterolateral to posteromedial direction. Local anesthetic will be injected posterior to QL muscle in QL2, while in QL3, it will be located between QL muscle and psoas major..QL2+3 blocks could be conducted in the same plane with only one puncture on each side The solution will be injected after negative aspiration to exclude vascular puncture 20
Control Group QLB C 30 ml normal saline in each side 48 hours all patients will be in the supine position, tilting 45 degrees to the opposed side in order to place the low-frequency convex probe properly and see the sonography clearly QLB will be underwent bilateral under ultrasonography guidance withnormal saline 30 mL on each side. Two regional anaesthesiologists experienced in peripheral nerve blocks will perform QLB or provided guidance. QLB will be performed with atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks, B. Braun Melsungen AG, Germany) advanced in-plane under the guidance of an ultrasound machine (X-Porte, Sonosite Ltd, USA) with a convex probe (2–5 MHz). With the patient in the supine position. The ultrasonogram of the abdominal wall could be displayed clearly through probe moving or tilting after the skin preparation with 2% chlorhexidine. Pillows could help to relieve the tension along the abdominal wall of patients. The whole procedure will be performed strictly according to clinical protocol. In this study, QLB C will be conducted through an anterolateral approach with the supine position . The ultrasound transducer will be placed transversely on both flanks at the horizontal level of L2-3 and will be adjusted until the “Shamrock sign” formed of QL muscle, psoas major and erector spinae will be visualized, with imaging depth set between 0 and 9.9 cm .Needles will penetrate in an anterolateral to posteromedial direction. Local anesthetic will be injected posterior to QL muscle 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists physical status of 1 or 2 who will be scheduled for elective gynecological surgery via a Pfannenstiel incision under general anesthesia Cognitive dysfunction Obesity (body mass index 35 kg/m2) Renal dysfunction (estimated glomerular filtration rate < 50) Coagulopathy, a drug allergy to NSAIDs, paracetamol or the local anaesthetic, Gastric ulcer, Pregnancy Regular opioid or steroid use. Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 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 17/03/2022 faculty of medicine alexandria
Ethics Committee Address
Street address City Postal code Country
17 Chamollion street ElMessalah alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome observe the effects of two practical QLB approaches, including type 2 and 3, as well as combination of QLB (2+3) in relieving postoperative pain following gynecological surgeries 48 hours
Secondary Outcome side effects and ambulation 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elshatby hospital elshatby street alexandria 21526 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 elshatby hospital elshatby street alexandria 21526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Yasser Essam Elfeil 5 Alomaraa Moharam beh Alexandria 21547 Egypt
Ehsan Akram Deghidy 5 Alomaraa Moharam BEH Alexandria 21547 Egypt
Hatem Baghat Ahmed Abo Elafa 370 El Horreya Avenue Moustafa Kamel Alexandria 21523 Egypt
Adel ibrahim Hassan Hozain 165 Elhoryea Elhadara Alexandria 21561 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 21547 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries ehsan deghidy drehsan.deghidy@yahoo.com 00201063199658 moharam beh
City Postal code Country Position/Affiliation
alexandria 21547 Egypt lecrurer of Biomedical Informatics and Medical Statistics
Role Name Email Phone Street address
Scientific Enquiries hatem wafa hatem_wafa@hotmail.com 00201155497711 370 El Horreya Avenue Moustafa Kamel
City Postal code Country Position/Affiliation
alexandria 21523 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 all data will be available
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