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.: PACTR202310583431901 Date of Approval: 20/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of High Thoracic Epidural Anaesthesia for Breast Surgeries
Official scientific title Effectiveness of High Thoracic Epidural Anaesthesia for Breast Surgeries: Randomized Control Trail (RCT)
Brief summary describing the background and objectives of the trial Epidural aneasethsia have always been linked with smooth postoperative course and favorable outcome especially in oncology patients; however, its usage as a sole agent in breast surgeries is not the standard practice till now. Concerns that minimized adoption of this anesthesia technique are axillary sparing due to the complicated breast innervation, fears of neurological complications occurrence, the concerns about the hemodynamic effects as severe hypotension and bradycardia. This study aimed to compare intraoperative and postoperative hemodynamics between patients who had epidural anaesthesia versus those who received general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/10/2023
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Epidural Variable dose of bupivacaine according to sensory level needed to be block Anesthesia dose: Intraoperative continuous infusion Analgesia dose: postoperative continuous infusion Thoracic epidural catheter will be placed by a Touhy needle under lidocaine local infiltration into a space between the 2th -6 th thoracic vertebrae. Intraoperatively: For breast procedures without transrectus abdominal muscle : An initial dose of (10 -15 cc) of 0.5% Bupivacaine; titrated incrementally to achieve sensory block from C5 to T6 For breast procedures with transrectus abdominal muscle reconstruction: An initial dose of 20 mL will be given incrementally to achieve sensory from C5 to L1 Infusion of 0.5% Bupivacaine 5 ml/h will be started 30 minutes after the initial epidural dose, and continued till the end of the procedure. Postoperatively: Epidural analgesia will start immediately postoperative in the form of 0.25- 0.125% bupivacaine epidural infusion by rate of of 5-8ml/ h. Insufficient analgesia (i.e: VAS> 3) will be managed by 10 ml boluses of 0.125% bupivacaine. 38
Control Group General anesthesia General anaesthesia will be induced with intravenous fentanyl, propofol and recrounim. General anaesthesia will be maintained by isoflurane according to body weight and patient response throughout the operation Intraoperatively: Induction with intravenous Fentanyl(2 mic/kg), Propofol (2-2.5 mg/kg ) and Recrounim(0.5-0.9 mg/kg). Maintainence: Isoflurane (MAC 1-2), and analgesic doses of Morphine(3-5mg). Paracetamol 1gm) and ketorolac (60mg)will be given intravenously 1/2 hbefore the end of the surgery. Postoperatively: Analgesia will start immediately postoperative in the form of IV-PCA morphine 20 mg / 24 h. Insufficient analgesia (i.e: VAS>3) will be managed by rescue boluses of 3-5 mg IV morphine. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for breast surgeries and reconstructive oncological surgeries. Patient refusal of epidural option. Uncooperative/ apprehensive patient/Psychiatric illness/ mental retardation Infection at the site of epidural insertion or sepsis. Considerable intraoperative pain during epidural anesthesia that necessitates supplementary local anesthetic infiltration or switch into general anesthesia. Failed epidural insertion and wet tap Coagulopathy and/or severe thrombocytopenia. Increased intracranial tension. Previous laminectomy. Preexisting central or peripheral neurological diseases. Severe spinal deformities. Severe aortic/ mitral valve stenosis. Complicated prolonged surgeries. Hypersensitivity to local anesthetics (LA) Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 28/08/2023 Kafr Elsheikh University Scientific Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
ElGish street Kafr Elshikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean arterial blood pressure Althrough operation and 24 hours postoperative
Primary Outcome Heart rate Althrough operation and 24 hours postoperative
Secondary Outcome Hospital stay Time to discharge
Secondary Outcome time to return of bowel motion in the first postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospital ElGish street Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hebatallah Fouad Dawood Building Number 2 Dream Compund, ElNassar Street, Smouha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia Department Faculty of Medicine Kafr Elshikh University El Gish street Kafrelsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hebatallah Fouad Dawood Building Number 2 Dream Compund, ElNassar Street, Smouha Alexandria 21648 Egypt
Mohamed Mamdouh Kotb Building Number 45 Street Number 314, Takseem AlKodaa, Smouha Alexandria 21646 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hebatallah Dawood Heba_fouad15@yahoo.com 00201010108228 Building Number 2 Dream Compund, ElNassar Street, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Anesthesia and surgical Intensive care Faculty of Medicine Kafr Elsheikh University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Kotb M_Kotb_86@hotmail.com 00201009538356 Building Number 45 Street Number 314, Takseem AlKodaa, Smouha
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Lecturer of Anesthesia and surgical Intensive care Faculty of Medicine Kafr Elsheikh University Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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