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.: PACTR202303833785332 Date of Approval: 31/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Ultrasound Guided Quadratus Lumborum Plane Block Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Relief in surgical treatment of endometriosis
Official scientific title Comparative Study between Ultrasound Guided Quadratus Lumborum Plane Block Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Relief in surgical treatment of endometriosis
Brief summary describing the background and objectives of the trial Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity and one of its common symptoms are chronic pelvic pain, dysmenorrhea, deep dyspareunia, dysuria and dyschezia. Surgical treatment of endometriosis is mostly indicated for pain relief or infertility that is refractory to clinical treatment, or advanced clinical spectrum of this disease, such as deep infiltrating endometriosis. Reducing the endometriotic foci is the main goal of surgery The objective of this study is to determine the effect of pre-emptive ultrasound guided quadratus lumborum plane block versus ultrasound guided erector spinae plane block for on intra- and postoperative pain control and opioid requirements in laparoscopic endometriosis procedures.
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 Endometriosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/06/2022
Actual trial start date 10/07/2022
Anticipated date of last follow up 01/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group QL block 0.25% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) 0.2 ml/kg (according to lean body weight) on each side 24 hours 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 where a solution will be injected on each side with care not to exceed the maximum safe dose. It will be located between QL muscle and psoas major. 15
Experimental Group ESB block 0.25% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) 0.2 ml/kg (according to lean body weight) will be injected on each side 24 hours . In the ESB group (E), the ultrasound-guided ESB will be performed by placing the patient in a lateral posture, having the side to be injected turned upward. A highfrequency linear ultrasound transducer had been sagittally positioned against thoracic vertebra 12 (T12) in the lateral posture and moved about 3-cm lateral to the spinous process of the spine. The tip of the transverse processes and the erector spinae muscle have been recognized, and a needle has been progressed in a plan from cephalic to caudal via the interfascial plane between the erector spinae and the underlying transverse process, followed by the injection of local anesthetic into the space between the two, with care not to exceed the maximum safe dose 15
Control Group Placebo Morphine on demand 24 hours No blocks only opioid on demand 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female genders undergoing laparoscopic endomertriosis surgery . coagulation defects hypersensitivity to bupivacaine contraindication to the use of NSAIDS sepsis at the site of injection conversion to laparotomy Adult: 19 Year-44 Year 18 Year(s) 45 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 16/06/2022 Faculty of medicine alexandria
Ethics Committee Address
Street address City Postal code Country
17 Chompollion Street Elmassalah Alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The objective of this study is to determine the effect of pre-emptive ultrasound guided quadratus lumborum plane block versus ultrasound guided erector spinae plane block for on intra- and postoperative pain control and opioid requirements in laparoscopic endometriosis procedures. 24 hours
Secondary Outcome time to first analgesic requirement, total morphine requirements during the first 24 h, time to first ambulation, incidence of shoulder pain, adverse effects and incidence of opioid side effects. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elshatby hospital Elshatby street Alexandria 00400 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal 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 1165 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 Dressing.deghidy@yahoo.com 00201063199658 Moharam beh
City Postal code Country Position/Affiliation
Alexandria 21547 Egypt Lecturer of Biomedical Informatics
Role Name Email Phone Street address
Scientific Enquiries Hatem Wafa Hatem_wafa@hotmail.com 00201155497711 370 Elhorreya 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