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.: PACTR201505001108423 Date of Approval: 19/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pectoral plane block versus Serratus Intercostal plane block
Official scientific title Ultrasound guided Pectoral plane block versus lateral approach Serratus Intercostal plane block in breast surgeries .
Brief summary describing the background and objectives of the trial The goal of the present study is to compare intra- and postoperative analgesic effect between US-guided lateral approach serratus intercostal plane block and US-guided pectoral plane block in non reconstructive breast surgeries and axillary clearance .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Breast surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2015
Actual trial start date 01/03/2015
Anticipated date of last follow up 31/03/2016
Actual Last follow-up date 31/03/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status 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 of 4 and the block size was not variable) 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 PECS block 40 ml LA 730 min Injection of LA bt pectors minor and serratus anterior at level thrid rib 30
Experimental Group SIP block 40 ml LA 730 min Injection of LA bt serratus anterior and external intercostal att level six rib 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American society of anesthesia I&II unilateral mastectomy 1- patient refusal 2- allergy to local anesthesia drugs or any included medication 3- reconstructive breast surgery 4- bilateral breast surgeries 5- sever liver disease and coagulopathy 6- sever renal disease 7-pychiatric disorder 8- pregnancy 9- morbid obesity 30 Year(s) 60 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 01/04/2015 Medical research institute
Ethics Committee Address
Street address City Postal code Country
165 Horreya road Al Hadara Aelxandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Opioids consumption in 24 hr postoperative
Primary Outcome VAS score in 24 hr postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical research institute 165 Horreya road Al Hadara Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical research institute 165 Horreya road Al Hadara Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anaesthesia Department - Medical research institute 165 Horreya road Al Hadara Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assem Abd El razk Abd Rabo 542 al horreya ,Avenve , Gleem Alexandria 21624 Egypt
Magada Mohamed Abo Ollo 24, Tot Ankh Amon , Somoha Alexandria 21516 Egypt
Sherif Ahmed Abd El Hamid 165 ,horreya, Al hadara Alexandria Egypt
Mariam Deifallah 165 Horreya road Al Hadara Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Magada Abo Ollo Magadaaboollo@hotmail.com 002-01222220214 24, Tot Ankh Amon , Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Mariam Deifallah Dr.mariamdeifallah@gmail.com 002-01221832698 67 dr abd el mohsen el hosany ,sidi besher
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Student in master degree of Anaesthesia
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information