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.: PACTR201405000632263 Date of Approval: 26/08/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided pectoral II block versus Thoracic paravertebral block for breast surgery
Official scientific title Ultrasound guided pectoral II block versus Thoracic paravertebral block for breast surgery
Brief summary describing the background and objectives of the trial Thoracic wall blocks (pectoral block i.e. infiltrating local anaesthetic (LA) between pectoralis major and minor muscles (PECS I), and and the modified pectoral block i.e. PECS II (including PECS I together with infiltrating local anaesthetic between pectoralis minor and serratus anterior muscle,and (Serratus plane block) are peripheral nerve block alternatives to paravertebral block for providing both surgical anesthesia and postoperative analgesia for breast surgery. All rely on LA placement between the thoracic wall muscles, where the sensory nerves supplying the breast run.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative analgesia for breast surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/09/2013
Actual trial start date 30/09/2013
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation table from a statistics book. Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guidance thoracic paravertebral block 30 ml of 0.25% bupivacaine at T3 level sinlge shot ultrasound guidance thoracic paravertebral block 50
Experimental Group ultrasound guidance pectoral II block 30 ml of 0.25% bupivacaine at T3 level sinlge shot ultrasound guidance pectoral II block 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
females presenting for breast surgery of American Society of Anesthesiologists (ASA)class I or II. Age 20-50 years Exclusion criteria included; patients suffered from Diabetes Mellitus, coagulopathy, infection at the site of block placement, and/or morbid obesity . 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
Yes 10/03/2014 Ethical committee of the 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 the analgesic and clinical efficacy of pectoral II block measuring intraoperative heart rate, mean blood pressure on reaching the operating theatre and every 10 minutes till end of procedure. measuring visual analogue score postoperatively at 30 minutes, 1, 6 , 12, and 24 hours. measuring the first time to require analgesia. measuring the first 24 hour postoperative analgesic consumption, and recording complications
Secondary Outcome comparing the analgesic efficacy compared to the ultrasound guided paravertebral block measuring intraoperative heart rate, mean blood pressure on reaching the operating theatre and every 10 minutes till end of procedure. measuring visual analogue score postoperatively at 30 minutes, 1, 6 , 12, and 24 hours. measuring the first time to require analgesia. measuring the first 24 hour postoperative analgesic consumption, and recording complications.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara 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 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Abdelhamid dr_shereif@hotmail.com 002034284659 165 horreya road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anaesthesia
Role Name Email Phone Street address
Public Enquiries sherif A bdelhamid dr_shereif@hotmail.com 0201001459756 165 horreya street-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Engy Yousry engi_yousry@yahoo.com 002034284659 165 horreya road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anaesthesia
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information