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.: PACTR201711002670315 Date of Approval: 06/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title compairing two method s of treatment of pain after modified radical mastectomy
Official scientific title Efficacy of serratus anterior plane block vs thoracic paravertebral block for pain relief after modified radical mastectomy
Brief summary describing the background and objectives of the trial background:Management of pain after modified radical mastectomy is important in order to protect respiratory reserves and decrease complications objectves:to compare serratus anterior plane(SAP) block versus thoracic paravertebral block for pain relief after modified radical mastectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SAPB Vs TPVB
Disease(s) or condition(s) being studied pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2017
Actual trial start date 07/10/2017
Anticipated date of last follow up 02/12/2017
Actual Last follow-up date 10/10/2017
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 40
Recruitment status Not yet 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TPVB 15-20 ml 0.25%bubivacaine was injcted before general anathesia TPVB 20
Experimental Group Bupivacaine 20ml SAPB 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II patients in the age group of ¿ 16-60 years male or female,160-190 Cm. undergoing elective thoracic surgery exclustion criteria : American Society of Anesthesia (ASA) III-IV, renal insufficiency (creatinine > 1.5 mg/dL),a history of opioid dependence, pregnancy, morbid obesity (body mass index > 40 kg/m2); chronic analgesia, history of sensitivty to local anathetic , bleeding disorders or reciving anticoagulant, spine or chest wall deformity 16 Year(s) 60 Year(s) Both
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 31/10/2017 zagazig faculty of medicine
Ethics Committee Address
Street address City Postal code Country
zagazig hospitals university street zagazig +20 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative analgesia Postoperative 24 hs
Secondary Outcome hypotension, tachycardia, purities,nausea,vomitin For 24hs postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
zagazig university hospitals zagazig university zagazig +20 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
zagazig university hospitals zagazig university zagazig +20 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zagazig university hospitals zagazig university zagazig +20 Egypt University
COLLABORATORS
Name Street address City Postal code Country
gehan fawzy ezz al khalifa al rashed zagazig +20 Egypt
Heba fathi zagazig university anathesia departement zagazig +20 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gehan Ezz fawzyezz@yahoo.com +20 01066525038 al khalifa al rashed
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectreur
Role Name Email Phone Street address
Principal Investigator Heba Fathi heba_elgendi@yahoo.com 01000143938 qawmia
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer
Role Name Email Phone Street address
Public Enquiries Heba Fathi heba_elgendi@yahoo.com 01000143938 qawmia
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer
Role Name Email Phone Street address
Public Enquiries osama khalifa yehia2001@hotmail.com 00201007579438 zagazig university
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer
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