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.: PACTR202108765231210 Date of Approval: 30/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Serratus Anterior Block versus Instillation of Local Anaesthetic through Surgical Drain in Modified Radical Mastectomy
Official scientific title Ultrasound Guided Serratus Anterior Block versus Instillation of Local Anaesthetic through Surgical Drain in Modified Radical Mastectomy
Brief summary describing the background and objectives of the trial Post mastetcomy pain is severe debilitating to the patient and increse risk of developing chronic pain syndrome in 25 % - 40 % of them .The main objective of the trial is to compare two diffirent techniques ( serratus anterior block versus instillation of local anesthetic in surgical drain ) in modified radical mastectomy surgery as regard analgesic effect , duration , hemodynamics , technique related complications .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0106538 Ethics committee , Faculty of medicine , Alexandria university
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 20 ml of bupivacaine 0.5 % , single injection single injection , post operative Ultrasound-guided Serratus anterior plane block will be carried out with the patients in the supine position.The proble will be held in the sagittal plane in the 5th intercostal space in the mid-axillary line targeting the plane between latissiumus dorsi muscle and serratus anterior muscle. 50
Control Group Group 2 20 ml of bupivacaine 0.25 % in each drain , single injection single injection , post operative LA instillation through drain group will be performed with the patient in supine position. Patients will receive total 40 ml of 0.25% bupivacaine , 20 ml in each surgical drain . 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patients Age 25-50 years old American Society Of Anesthesiologists (ASA) class I or II scheduled for elective unilateral modified radical mastectomy. Patient refusal. Skin infection at the site of injection. Bleeding disorders or receiving anticoagulant. Spine or chest wall deformity . Body mass index more than 35 kg/m2. Patient inability to properly describe postoperative pain to the observer (dementia, delirium, psychiatric and neurological disorder). History of allergy or contraindication to any of the studied drugs. Reconstructive breast surgery. Chronic analgesic abuser . Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 50 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 17/09/2020 Ethics committee of Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University , 17 Champollion street , Alexandria , Egypt Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Analgesic effect using VAS (visual analogue score) in the first 24 post-operative hours. Duration of the analgesic effect of the procedure . Post-operative analgesia including first demand of analgesia and total opioids consumption over 24 post-operative hours. 30 minutes after completion of the tecnique then at 2 , 4 , 6 , 12 , 18 , 24 hours postoperative
Secondary Outcome Technique related complication Patient satisfaction 30 minutes after completion of the tecnique then at 2 , 4 , 6 , 12 , 18 , 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospital Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Main University Hospital Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Main University Hospital Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Reem Essam Eid 54 Zeinah street, Sidi Bishr, Alexandria, Egypt Alexandria 21611 Egypt
Ahmed Ayman Antoniads compound , Block 9 , Al Matar , Alexandria , Egypt Alexandria 21623 Egypt
Aly Aboshady Tanees St , Block 149 , Sporting , Alexandria ,Egypt Alexandria 21617 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrahman Kamal a_abdelfattah18@alexmed.edu.eg +201069782461 End of Amena Nageeb St , Awal Al Ramal
City Postal code Country Position/Affiliation
Alexandria 21527 Egypt Anesthiologist at Faculty Of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mansour am9277287@gmail.com +201119277287 Champollion Street , El-Khartoum Square , Azarita Medical Campus
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Rabab Saber roba98@hotmail.com +201223497339 Champollion Street El-Khartoum Square Azarita Medical Campus
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Assistant Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes An excel sheet of the data will be shared once the recruitment is complete Study Protocol five years To those who request the data via e-mail of the principal investigator according to the cause of request.Please contact a_abdelfattah18@alexmed.edu.eg
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