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.: PACTR201506001127186 Date of Approval: 01/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ultrasound guided pectoral plane block versus direct surgical interpectoral analgesia
Official scientific title ultrasound guided pectoral plane block versus direct surgical interpectoral analgesia
Brief summary describing the background and objectives of the trial Many techniques were tried for postoperative pain relief following mastectomy.however, each technique has its own difficulties, variable success rate, may be difficult to use and with unpredictable effect.in this study we aim to evaluate postoperative analgesia score using ultrasound guided pectoral plane (PEC) block versus direct surgical interpectoral analgesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/05/2015
Actual trial start date 30/07/2015
Anticipated date of last follow up 30/07/2015
Actual Last follow-up date 30/07/2015
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
reporting any difficulties or complications
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 imple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guided pec block 40 ml 0.25% bupivacaine single shot ultrasound guided pectoral plane block 30
Experimental Group open surgical interpectoral instillation of local anesthetic 40 ml 0.25% bupivacaine single shot intraoperative open surgical interpectoral instillation of local anesthetic 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
females ASA II undergoing breast surgery of 30-50 years coagulopathy patient refusal allergy to local anesthetics infection at site of injection 30 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 04/05/2015 medical research institute
Ethics Committee Address
Street address City Postal code Country
165 horreya road Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluating postoperative analgresia 30 minutes postoperative measuring the visual analogue scale then every 2 hours for 24 hours
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 street 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 University
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 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-Alexandria university
Role Name Email Phone Street address
Public Enquiries Engy yosry dr_shereif@hotmail.com 01001459756/002 165 horreya road Alhadara
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 yasser Hamed dr_shereif@hotmail.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of surgery-medical research institute-Alexandria university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information