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.: PACTR202204718711277 Date of Approval: 14/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound guided erector spinae plane block versus quadratus lumborum block in upper abdominal surgeries
Official scientific title Ultrasound guided erector spinae plane block versus quadratus lumborum block in upper abdominal surgeries
Brief summary describing the background and objectives of the trial comparison between analgesic efficacy of ultrasound guided erector spinae plane block and quadratus lumborum block for acute postoperative pain management in upper abdominal surgeries using 24h total postoperative analgesic consumption , first time to analgesic request , visual analogue scale pain score (VAS) during rest and movement, perioperative hemodynamic parameters and any postoperative adverse effects like (shivering, pururitis, nausea and vomiting).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/05/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 01/09/2022
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ultrasound guided erector spinae plane block 20 ml of isobaric bupivacaine 0.25% in each side 24 hours Before induction of general anesthesia and after premedication with 2 mg midazolam ,erector spinae plane block is performed using ultrasound (after putting the patient in a sitting position with a support from a member staff. Taking C7 as a reference,the T7 spinous process is identified by palpation, placing high frequency (5-10 MHz)linear probe over the spinous process then slipping it laterally approximately 3 cm until the transverse process is identified. At this point, under complete aseptic condition 3 ml of 2% lidocaine is administrated. Longitudinal rotation of the probe and the puncture is performed in the craniocaudal direction following the previous infiltration with a local anesthetic. A 22-gauge 100 mm spinal needle is inserted in-plane of the ultrasound beam and directed towards the transverse process. When it contacts the transverse process, 2 ml of saline 0.9% is injected. The injectate is observed spreading underneath the erector spinae muscle lifting the muscle of the transverse process. After hydro dissection, 20 mL of isobaric bupivacaine 0.25% is injected with frequent aspiration to avoid intravascular injection. The procedure is repeated in a similar fashion on the contralateral side. After 15 min pain block is assessed by hollman scale for sensory block using pin brick .All patients undergo institutional general anesthesia protocol. Intraoperative heart rate (HR), mean arterial blood pressure(MAP), Oxygen saturation (spo2) are recorded every 5 min for 15 min then every 30 min till end of the surgery. After induction of GA, iv infusion of paracetamol (15 mg/kg) and ketorolac 30 mg are given to all patients and then every 8 hours. Fentanyl boluses (0.5 µg/kg) are given for any rise in intraoperative mean arterial blood pressure or heart rate more than 20% of baseline and postoperative as a rescue analgesia if VAS score ≥ 3 and it might be repeated after 30 minutes until VAS is ≤ 3 . 44 Dose Comparison
Experimental Group Ultrasound guided quadratus lumborum block 20 ml 0.25% isobaric bupivacaine 24 hours Before induction of general anesthesia and after premedication with 2 mg midazolam, quadratus lumborum block is performed using ultrasound.The patient is positioned laterally. Under complete aseptic condition, using high-frequency linear probe (5-10 HZ) abdominal wall muscles are identified. The probe is directed posteriorly and the fascia transversalis (TF), thoracolumbar fascia and Quadratus lumborum (QL) muscle are visualized. After administration of 3 ml of 2% lidocaine, 22- G 100 mm spinal needle is introduced in plane and its tip is placed at the posterior edge of the QL muscle. 20 ml of 0.25% isobaric bupivacaine is injected between QL and middle layer of thoracolumbar fascia. The same technique is done in the opposite site .After 15 min pain block is assessed by hollman scale for sensory block using pin brick .All patients undergo institutional general anesthesia protocol. Intraoperative heart rate (HR), mean arterial blood pressure(MAP), Oxygen saturation (spo2) are recorded every 5 min for 15 min then every 30 min till end of the surgery. After induction of GA, iv infusion of paracetamol (15 mg/kg) and ketorolac 30 mg are given to all patients and then every 8 hours. Fentanyl boluses (0.5 µg/kg) are given for any rise in intraoperative mean arterial blood pressure or heart rate more than 20% of baseline and postoperative as a rescue analgesia if VAS score ≥ 3 and it might be repeated after 30 minutes until VAS is ≤ 3 . . 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Age between 18-60 years.  Either sex.  American society of anesthesiologists (ASA) physical status class I or II.  Patients scheduled for elective upper abdominal surgery under general anesthesia.  Patient refusal  Emergent and urgent operations.  History of allergy to any drugs of the study.  Coagulation disorder.  Infection at puncture site.  Pregnancy.  Chronic treatment with opioids or NSAIDS.  Uncooperative patients. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 22/04/2020 Inistitutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 EL GOMHORIA SREET mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 24 hour total postoperative analgesic consumption 1, 6, 12, 18, 24
Secondary Outcome first time analgesic request , VAS ,perioperative haemodynamics , postoperative adverse effect 1, 6, 12, 18, 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospital 2 El gomhoria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 elgomhoria street mansoura 36616 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Abdul aziz Abdul monteleb mutawea 2 el gomhoria street mansoura 35516 Egypt
Hazem Elsayed moawad Weheba 2 EL-Gomhouria Street Mansoura 35516 Egypt
Ahmed Mohamed sonbol 2 El-Gomhouria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aalaa Qassem aalaa.mohammed@hotmail.com +201003707068 2 El- Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant lecturer of anesthesia and surgical intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Abd ul Aziz Mutawea abdelazizmetawee@mans.edu.eg +201018550482 2 El- Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of anesthesia and intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Hazem Weheba hazemmoawad@yahoo.com +201121516041 2 El- Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant Professor of anesthesia and surgical intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Sonbol dr.sonbol@gmail.com +201003735129 2 El- Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form begining 6 month and ending 12 monthsfollowing article puplication we will provide individual participant data and share it through the PubMed indexed journal
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