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.: PACTR201607001697375 Date of Approval: 27/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
Official scientific title Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
Brief summary describing the background and objectives of the trial The aim of the study is to evaluate the effect of pre-emptive ultrasound guided Quadratus Lumborum block versus ultrasound guided Transversus Abdominis Plane block on acute postoperative pain in patients undergoing laparoscopic cholecystectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic calcular cholecystitis,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2016
Actual trial start date 01/07/2016
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date 31/01/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size was variable minimum of 4) 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 Transversus abdominis 20 ml bupivacaine 0.25 % Before induction of general anaesthesia Ultrasound guided bilateral TAP block. local anaesthetic will be injected in the fascial plane between the internal oblique and transverses abdominis muscles. 25
Experimental Group Quadratus lumborum group 20 ml bupivacaine 0.25 % Before induction of general anaesthesia Ultrasound guided bilateral QLB. local anaesthetic will be injected in the fascial plane between the QL and Psoas major muscles 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with chronic calcular cholecystitis. - American Society of Anaesthesiology (ASA) physical status I or II, scheduled for laparoscopic cholecystectomy. - Allergy or contraindication to any of the studied medications or anaesthetic agents. - Patients on anticoagulation therapy. - Chronic opioid analgesic use. - Pregnancy. - Infection at the site of injection or any other contraindication for regional anaesthesia. - Complicated cases 20 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 15/06/2016 Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
El Azerita Square Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) (1-10) Every hour for the first 4 hours and then every 4 hours for the rest of the 24 postoperative hours.
Secondary Outcome Total amount of intravenous morphine patient controlled analgesia over the first 24 postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical research institute Elhouria road, Elhadara Elbahria Alexandria 21561 Egypt
Alexandria main university hospital El Azerita Square Alexandria 21563 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Anesthesia Department, Medical Research Institute Elhouria road, Elhadara Elbahria Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia Department, Medical Research Institute Elhouria road, Elhadara Elbahria Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mervat Moustafa Abd El Maksoud St.6 Moustafa Kamel Smouha Alexandria 21615 Egypt
Magdy Abd El-Aziz Mansour 95 Moustafa Kamel Sidi Gaber Alexandria 21523 Egypt
Marwan Abd El Zaher El Fakharany 4042 Mohamed Bek Elserafy Miami Alexandria 21614 Egypt
Ahmed Mohamed Mohamed Rabah AbdAllah Shahr Elasal street Bitash Dekhila Alexandria 21928 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mervat Moustafa Abd El Maksoud Mervat_abdelmaksoud@hotmail.com 00201007018359 St.6 Moustafa Kamel Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Professor of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, University of Alexandria
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 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Magdy Abd El-Aziz Mansour drmagdy13@yahoo.com 00201223409422 95 Moustafa Kamel Sidi Gaber
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Professor of Anaesthesia Medical Research Institute, University of Alexandria
REPORTING
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Changes to trial information