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.: PACTR202107535738159 Date of Approval: 30/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between Erector Spinae Plane Block with General Anesthesia versus Conventional Intravenous Analgesics with General Anesthesia in Patients undergoing Conserving Surgery for Breast Cancer
Official scientific title A Comparative Study between Erector Spinae Plane Block with General Anesthesia versus Conventional Intravenous Analgesics with General Anesthesia in Patients undergoing Conserving Surgery for Breast Cancer
Brief summary describing the background and objectives of the trial Acute postoperative pain is common after breast surgery, and despite conventional pain management, a large number of patients respond poorly to analgesics.Thoracic epidural, thoracic paravertebral block, pectoral block, and serratus plane block are commonly used techniques of regional anesthesia for breast surgery. All these techniques have their merits and demerits. Erector spinae plane block (ESPB) is a newer technique of regional anesthesia to the chest wall, where local anesthetic is deposited between the transverse process and erector spinae muscle resulting in analgesia to the hemithorax. Aim of this study is to assess the efficacy of ultrasound guided erector spinae plane block using 0.25% bupivacaine versus conventional multimodal intravenous analgesia on postoperative pain control after conserving surgery for breast cancer The primary outcome measure of the study is amount of postoperative opioid consumption ,the secondary outcomes of the study are the visual analog scale (VAS), hemodynamic parameters, and rate of complications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial pain management
Anticipated trial start date 15/04/2021
Actual trial start date
Anticipated date of last follow up 15/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Active, not 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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional Intravenous Analgesics with General Anesthesia in Patients undergoing Conserving Surger before start of surgery and for 24 hours post operative Conventional Intravenous Analgesics with General Anesthesia in Patients undergoing Conserving Surgery for Breast Cancer 27 Active-Treatment of Control Group
Experimental Group erector spinae plane block before start of surgery and for 24 hours post operative erector spiane plane block in Patients undergoing Conserving Surgery for Breast Cancer 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a- Patients American Society of Anesthesiologists , physical status (ASA) II to III . b- Females scheduled for conserving surgery for breast cancer . c- Aged ≤65 years old. a) Patients with major spine deformities. b) Patients with bleeding disorders and coagulopathy. c) Infection at the injection site. d) Allergy to local anesthetics. e) Patients with pre-existing myopathy or neuropathy. f) Patients with significant cognitive dysfunction. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 18/11/2020 Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
abbasia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure of the study is post operative pain assemsmentusing vas score 24 hours
Secondary Outcome The secondary outcomes of the study are the total amount of opioid consumption, time for first rescue dose analgesi , hemodynamic parameters, and rate of complications 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
el demerdash hospital faculty of medicine ain shams university 56 Ramsis St., Abbasseya, Cairo. cairo 11588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Islam abd elfadel abd elhakim 2 ibrahem nagy street nasr city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university abbasia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Islam abd elfadel abd elhakem 2 ibrahem nagy street nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator islam abd elfadel abd elhakem ahmed islamabdelfadel@hotmail.com 01096584405 ibrahim nagy streat
City Postal code Country Position/Affiliation
cairo 11865 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries mohamed saleh drsalehm2002@outlook.com 01227761463 nasr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries gamal fouad gamalzaki@gmail.com 01222401438 nasr city
City Postal code Country Position/Affiliation
cairo Egypt prof
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelrahman Ahmed_abdelrahman1985@hotmail.com 01003074795 Fifth settlement
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal Proposal may be submitted up to 36 months following article publication. After 36 months the data will be available in out University’s data warehouse but without investigator support other than deposited metadata.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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