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.: PACTR201510001082126 Date of Approval: 24/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title serratus anterior plane versus pectoral plane (PECS) block
Official scientific title ersus pectoral plane (PECS) block
Brief summary describing the background and objectives of the trial many techniques have been used for anesthesia and analgesia for breast surgery. in this trial we aim to compare two ultrasound guided techniques to produce anesthesia and analgesia of the dermatomes involving breast surgery; namely the pecs block and serratus anterior block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied analgesia for breast surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/03/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 09/09/2015
Actual Last follow-up date 17/09/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group serratus anterior plane block 40 ml 0.25% bupivacaine single shot serratus anterior plane block 25
Experimental Group pectoral plane block 40 ml 0.25% bupivacaine single shot ultrasound guided pectoral plane block 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female patients ASA I-II 20-50 year old morbidly obese ASA III patients Hypersensitivity to the local anesthetic diabetics or with neuropathic disease 20 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
No 01/04/2015 Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
165 Horreya Road-Alhadara- Alexandria Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anesthesia and analgesia for breast cancer surgery -at 5 minute interval following the block to assess sensory block -vital signs; baseline and following skin incision , then every 5 minutes intraoperative for 30 minutes then every 10 minutes till end of surgery -visual analogue scale on recovery and every 30 minutes for 4 hours then every 2 hours for 24 hours
Secondary Outcome ambulation ability -length of hospital stay -patient satisfaction
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical research institute 165 horreya road -Alhadara -Alexandria Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Institute 165 horreya road -Alhadara -Alexandria Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute 165 horreya road -Alhadara -Alexandria Alexandria 21561 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute 165 horreya road -Alhadara -Alexandria Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Abdelhamid dr_shereif@hotmail.com 002-01001459756 165 horreya road Alexandria
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anesthesia and surgical intensive care-Medical Research Institute-Alexandria University
Role Name Email Phone Street address
Public Enquiries Engy Yousry engi_yousry@yahoo.com 002-01001459756 165 horreya road Alexandria
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anesthesia and surgical intensive care-Medical Research Institute-Alexandria University
Role Name Email Phone Street address
Scientific Enquiries sherif Abdelhamiid dr_shereif@hotmail.com 01001459756 165 horreya street Alexandria
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia-medical research institute Alexandria university
REPORTING
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Result URL Hyperlinks
Changes to trial information