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.: PACTR202001789968542 Date of Approval: 15/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic effect of addition of pecto-intercostal block to serratus anterior plane block in breast surgeries: A Randomized controlled trial
Official scientific title Analgesic effect of addition of pecto-intercostal block to serratus anterior plane block in breast surgeries: A Randomized controlled trial
Brief summary describing the background and objectives of the trial Ultrasound-guided interfascial plane blocks are considered one of the recent modalities for effective perioperative analgesia in breast surgeries. The serratus anterior plane block (SAPB) has been used effectively and safely for the management of perioperative pain for breast surgeries. SAPB cannot block effectively the anterior cutaneous branches of the intercostal nerves and do not provide adequate analgesia near the sternum and in the inner quadrant of the breast, thus new blocks have been developed to overcome this issue, for example, pectointercostal fascial plane block (PIFB). The pecto-intercostal fascial block (PIFB) consists of injecting a local anesthetic (LA) between the pectoralis major muscle and the external intercostal muscle to block the anterior cutaneous branches of the intercostal nerves that penetrate through these two muscles to innervate the internal mammary area. The aim of the study is to evaluate the role of PIFB as a supplement to SAPB. The primary outcome of this study is to evaluate the use of pectointercostal plane block in addition to SAPB on the total opioid consumption and on the postoperative pain score. The secondary outcome is intra- and post-operative hemodynamic stability.
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 Treatment: Drugs
Anticipated trial start date 15/02/2020
Actual trial start date
Anticipated date of last follow up 15/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 Permuted block randomization 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 SAPB and PIFB 30 ml of 0.25% Bupivacaine for SAPB + 10 ml of 0.25% Bupivacaine for PIFB 24 hours Ultrasound guided serratus anterior plane block+ pectoinercostal fascial plane block 20
Control Group SAPB 30 ml of 0.25% bupivacaine for SAPB 24 hours Ultrasound guided serratus anterior plane block 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-III Conservative breast surgeries Mastectomies Breast lump excision Patient refusal. ASA>III Bilateral breast surgeries Reconstructive breast surgeries Allergies to any of the used medications. Coagulopathies. Infection. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 21/11/2019 Ethics Committee of Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total opioid consumption. During the first 24 hours postoperative
Primary Outcome Postoperative pain score 24 hours postoperative
Secondary Outcome Intraoperative hemodynamic stability Intraoperative and 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Madina womens hospital 25 elshaheed kamal el deen salah ezbet saad sidi gaber Alexandria 21529 Egypt
Medical research institute 165 Horreya road Al Hadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Mahmoud Soliman Yakout 397 El-Horreya Avenue Mustafa Kamel Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Madina womens hospital 25 elshaheed kamal el deen salah ezbet saad sidi gaber Alexandria 21529 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hatem Baghat Ahmed Abo Elwafa 370 El-Horreya Avenue Mustafa Kamel Alexandria 21523 Egypt
Amr Mohamed Helmy Alfred Layan street Roushdy Alexandria 21529 Egypt
Hala Mohamed Koptan 21 Tout Ankh Amoun Somuha Alexandria 21615 Egypt
Maha Mahmoud Soliman Yakout 397 El-Horreya Avenue Mustafa Kamel Alexandria 21523 Egypt
Adel Ibrahim Hassan Hozien 165 Elhoryea Street Elhadara Alexandria 21561 Egypt
Yasser Esaam Elfeil 5 elomraa street Alexandria 21547 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Hozien adelhozien49@gmail.com 00201066062582 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Hatem AboElwafa hatem_wafa@hotmail.com 00201155497711 370 Elhorrya Avenue Mustafa kamel
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
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 Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) 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