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.: PACTR202209469190581 Date of Approval: 08/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect Of Quadratus Lamborum versus Epidural Block on Perioperative Hemodynamic Status in Elderly Patients with Cancer Colon Surgery
Official scientific title Effect Of Quadratus Lamborum versus Epidural Block on Perioperative Hemodynamic Status in Elderly Patients with Cancer Colon Surgery
Brief summary describing the background and objectives of the trial Epidural analgesia becomes the standard method for postoperative pain management after major abdominal surgery as it decreases the stress response to surgery, decreasing the level of inflammatory mediators as IL-6, and allows better analgesic effect compared to intravenous opioids. However, it has many complications as hypotension, bradycardia, hematoma at the site of insertion, infection, injury of the spinal cord and intrathecal catheter placement. Quadratus lamborum block is an US regional nerve block where the local anaesthetic drug is injected using different approaches (anterior, posterior, lateral, transmuscular and recently subcostal) into the space surrounding the quadratus lamborum muscle and the block level can extend from 7th thoracic to 4th lumbar segment according to which approach is used. Most patients who undergo colorectal surgery especially extensive bowel resections and emergency laparotomies, may show acute changes in the volume status and in the composition of intracellular and extracellular fluids. Good perioperative management of fluids is very important to obtain good outcomes after surgery, especially in the elder group who already suffer from comorbidities such as hypertension, diabetes mellitus, ischemic heart disease, and cerebrovascular stroke. Fluid responsiveness can be assessed by static measures such as central venous pressure, urine output and blood pressure or dynamic measures like pulse contour analysis (PiCCO, LiDCO) and plethysmography variability index (PVI) (Masimo PVi®), which are better in predicting fluid responsiveness. The aim of this study is to compare between the subcostal approach of quadratus lumborum block and epidural block on perioperative hemodynamic status in elderly patients with cancer colon surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/09/2022
Actual trial start date
Anticipated date of last follow up 15/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization 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 Bilateral US guided subcostal approach of QLB 30 ml of concentration 0.25% bupivacaine and 4 mg dexamethasone on each side as a single shot with 1: 200,000 adrenaline with total maximum dose of bupivacaine 2mg/kg. 30 minutes before surgery US probe will be placed below the 12th rib in a parasagittal oblique plane tilted medially at L1-2 level. The QLM can be visualized at below the 12th rib, and the LD muscle will be seen superficial to the QLM.Moving the probe further medially until Erector spinae muscle can be visualized posteriorly, and the Psoas Major Muscle anterior to the QLM then LA will be injected between QLM and posas muscle using in plane technique. 20
Control Group Lower thoracic epidural analgesia EA with general anaesthesia. A bolus dose of (0.1-0.15 ml/kg) of 0.25% bupivacaine will be given slowly in the epidural catheter then a continuous infusion of 6 ml/h 0.25% bupivacaine will be maintained 30 minutes before surgery lower thoracic epidural will be performed using an 18-gauge Touhy epidural needle by a median approach at level T10-11. After negative aspiration test for blood and cerebrospinal fluid, a test dose of 3 mL of 2% lidocaine with 1: 200,000 adrenaline will be given after the placement of the epidural catheter. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elderly patients with American Society of Anesthesiology Physical Status II or III scheduled for open colorectal surgeries. Patient refusal. Allergy to local anaesthetic drugs or any included medications. Coagulopathy or patients on anti-coagulant. Preoperative cognitive dysfunction. Contraindications to epidural analgesia or QLB. Body mass index (BMI) > 35. Aged: 65+ Year(s) 65 Year(s) 85 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 21/07/2022 Ethics Committe of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean arterial blood pressure be recorded before the block, intraoperative every 15min and postoperative every 10 min for the 1st hour then every 4 hour in the next postoperative 24 hour.
Primary Outcome fluid management using PVI Intraoperative PVI will be recorded every 15 min.
Secondary Outcome VAS score VAS upon arrival from the operating room time 0 then at 2, 6, 12, and 24 hours
Secondary Outcome the total amount of opioids needed in the first postoperative 24 hours Total opioid at the end of postoperative 24 hours.
Secondary Outcome IL-6 before the block and after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Surgery Medical Research Institute Hospital Alexandria University 165 El-Horeya Rd, Al Ibrahimeyah Qebli and Al HadrahBahri, Qesm Bab Sharqi, Alexandria Governorate Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Lina Gamal Mahmoud Rizk 10 El kazeno street San stefano Alexandria 21532 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of surgery medical research institute hospital Alexandria university 165 El-Horeya Rd, Al Ibrahimeyah Qebli and Al HadrahBahri, Qesm Bab Sharqi, Alexandria Governorate Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Eldin Abd El Monem Arida 17 Champolion St., Azarita Alexandria 21521 Egypt
Magdy Abdelaziz Mansour 165 El-Horeya Rd, Al Ibrahimeyah Qebli and Al HadrahBahri, Qesm Bab Sharqi, Alexandria Governorate Alexandria 21561 Egypt
Shahira Ahmed Mohamed Elmetainy 17 Champolion St., Azarita Alexandria 21521 Egypt
Lina Gamal Mahmoud Rizk 10 El kazeno street San stefano Alexandria 21532 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Eldin Arida aridae@yahoo.com 002034862506 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Anaesthesia and Surgical Intensive care Faculty of Medicine Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Magdy Mansour drmagdy13@yahoo.com 002034297624 165 El-Horeya Rd, Al Ibrahimeyah Qebli and Al HadrahBahri, Qesm Bab Sharqi, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anaesthesia and Pain Management Medical Research Institute Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data, please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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