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.: PACTR202110858627849 Date of Approval: 22/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between ultrasound guided transversus abdominis plane block and Quadratus Lumborum block for open nephrectomy surgeries
Official scientific title Comparison between ultrasound guided transversus abdominis plane block and Quadratus Lumborum block for open nephrectomy surgeries
Brief summary describing the background and objectives of the trial The aim of the present study is to compare the efficacy of transversus abdominis plane (TAP) block versus quadratus lumborum (QL) block applied under US guidance as methods of postoperative analgesia in open nephrectomy surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2021
Actual trial start date
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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
Control Group ultrasound guided transversus abdominis plane block will receive 0.3-0.4 ml/kg of 0.25% pubivacaine on the side of operation its a regional block The TAP block or the QL block will be performed on the side of operation at the end of the surgery and before extubation by the anesthesiologist. In a TAP block,with the patient in supine position, strict aseptic measures will be taken.The transducer is placed between the iliac crest and costal margin, and three muscle layers were identified (external oblique, internal oblique, and transversus abdominis muscles).After identifying the TAP, the needle is guided through the subcutaneous tissue,external oblique,and internal oblique. When the needle reached the plane between the internal oblique and the transversus abdominis.The location of the needle is verified by inject 3 ml normal saline and 0.3-0.4 ml/kg of local anesthetic will be injected into this plane. 40 Dose Comparison
Experimental Group quadratus lumborum block Q will receive 0.3-0.4 ml/kg of 0.25% pubivacaine on the side of operation its a regional block QL block, with the patient in lateral position a linear transducer is placed between the iliac crest and costal margin in the midaxillary line and moved posteriorly so that the posterior aponeurosis of the transversus abdominis muscle is visible. The needle will be targeted deep to the aponeurosis and superficial to the transversalis fascia, at the lateral margin of QL muscle. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Age group: 21-60 years old o Sex: both sexes o ASA I and II o Patient undergo open nephrectomy surgery o ASA III and IV o Patient refusal o Mental illness o History of alcohol or analgesic dependence o Coagulopathy o Severe hepatic dysfunction o Chronic pain o Infection at site of needle insertion o Allergy to local anesthetic o BMI more than 30kg/m2 or less than 15 kg/m2 Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 23/05/2021 research ethics committee at faculty of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
faculty of medicine ain shams university,56 ramses street cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total pethedine consumption for 24 hrs Postoperative in both groups. 24 hours
Secondary Outcome Postoperative pain score evaluated by VAS score will be recorded every 4 hrs postoperative Time of First dose rescue analgesia needed if VAS score ˃ 4 Pethedine-related side effects included nausea and vomiting, dizziness,hyoxemia, pruritis Cardio vascular and neurological complications of local anesthetics. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university gospital 56 ramses street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ain shams university abbasya cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university abbasya cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator galal afifi drgalal55@gmail.com 00201001513934 5th settlement
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Public Enquiries mohamed shokeir shokeir_hossam@yahoo.com 00201065364614 nasr city
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries ghada El Saeid dr.ghada216@gmail.com 00201005043691 nasr city
City Postal code Country Position/Affiliation
cairo Egypt assistant professor
Role Name Email Phone Street address
Principal Investigator doaa mohamed mkjamaluddeen@hotmail.com 00201005667050 abbasya
City Postal code Country Position/Affiliation
cairo Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
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