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.: PACTR201605001385188 Date of Registration: 08/12/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title thoracic epidural vs modified pectoralis block vs serratus anterior block in breat surgery
Official scientific title Comparative Study Between Preemptive Analgesia of Thoracic Epidural Block , Ultra-Sound Guided Modified Pectoralis Block and Serratus Plane block for Breast Surgery
Brief summary describing the background and objectives of the trial Surgical pain is a universal phenomenon affecting patients intraoperatively and postoperative period. acute pain has several deleterious effects on the physical status and the psychic state of the patient.so the objective of this study is to compare the preemptive analgesia of thoracic epidural block, ultra-sound guided modified pectoralis block and serratus plane block for women undergoing breast surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2014
Actual trial start date 01/12/2014
Anticipated date of last follow up 01/06/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known (2701/08/14)
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 table created by computer soft ware program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group thoracic epidural block 7ml of bupivacaine 0,25% 6 hours 30 Active-Treatment of Control Group
Experimental Group modified pectoralis block 10 ml of bupivacine 0.25% in pectoralis block I 20 ml of bupivacine 0.25%in pectorlais block II 6 hours 30 Active-Treatment of Control Group
Experimental Group serratus anterior plane block 40 mL of (bupivacine 0.25%) will be injected between latissimus dorsi and serratus anterior at the 5th rib level in the mid axillary line. 6 hours 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 20 - 65 years ASA class I and II scheduled for breast surgeries past history of coagulation disorders spine or chest wall deformity uncontrolled chronic medical disease e.g (renal or hepatic failure) known allergy to local anaesthetics or opioid obese patients with body mass index (BMI) ¿ 30 patients on opioid treatment 20 Year(s) 65 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 ethics committe in faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
el geish street tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevent post operative pain 1hour 3rd hour 6th hour 12hour 18 hour and 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital el geish street tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospitals el geish street tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospitals El Giesh street Tanta Tanta 31257 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
prof.Abdelraheem Mostafa Dowidar El Geish Street Tanta 31257 Egypt
Hoda Alsaid Ezz El Geish Street Tanta 31257 Egypt
Rehab Said Elkalla El Geish Street Tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina el malla dr_dina90@yahoo.com +201005336059 el geesh street
City Postal code Country Position/Affiliation
Tanta 31111 Egypt assistant lecturer of anaesthesia and surgical ICU - Faculty of medicine
Role Name Email Phone Street address
Public Enquiries Hoda Ezz hodaezz714@yahoo.com +201222768250 el geesh street
City Postal code Country Position/Affiliation
Tanta 31111 Egypt Assistant Professor of anaethesia and surgical ICU -Tanta faculty of medicine
Role Name Email Phone Street address
Public Enquiries rehab el kalla Rehouba10@hotmail.com +201285700765 el geesh street
City Postal code Country Position/Affiliation
Tanta 31111 Egypt lecturer of anaesthesia and surgical ICU - Faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Abd el raheem Dowidar Dr.dowidar47@hotmail.com +201223195015 el geesh street
City Postal code Country Position/Affiliation
Tanta 31111 Egypt prof of anaesthesia and surgical ICU -Tanta faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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