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.: PACTR202106819955901 Date of Approval: 17/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector Spinae Plane Block versus Posterior Deep Approach of Serratus Anterior Plane Block for Nociceptive and Neuropathic Pain in Modified Radical Mastectomy
Official scientific title Erector Spinae Plane Block versus Posterior Deep Approach of Serratus Anterior Plane Block for Nociceptive and Neuropathic Pain in Modified Radical Mastectomy
Brief summary describing the background and objectives of the trial Cancer breast is the most common cancer in women and the second most common cancer all over the world. It is the fifth cause of death from cancer in women according to the International Agency of Research On Cancer and WHO. The management of post-mastectomy pain is multimodal which could be pharmacological or non-pharmacological treatments. The pharmacological treatment includes paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressants, and selective serotonin-reuptake inhibitors while non-pharmacological treatment like acupuncture and trans-electrical nerve stimulationRegional blocks are now considered more effective in the management of postoperative pain. The regional blocks could be neuroaxial like thoracic epidural or peripheral nerve blocks like paravertebral block, pectoralis blocks (PEC1 and PECS2), serratus anterior plane blocks (SAPB), and erector spinae plane block (ESPB). The aim of this work is to compare the efficacy of Erector Spinae Plane block (ESP block) versus the posterior approach of serratus anterior plane block (SAP block) as regard control of postoperative pain in modified radical mastectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/06/2021
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 Erector Spinae Plane Block 20 ml of 0.25% bupivacaine and 8 mg dexamethasone. 20 Minute before operation patient will be placed in the lateral position with the operative site is the uppermost. After skin disinfection and draping; screening The probe will be placed at the parasagittal plane 2cm lateral to the 4th thoracic spine on the same side of surgery. 25
Control Group Serratus Anterior Plane Block 20 ml of 0.25% bupivacaine and 8 mg dexamethasone 20 Minute before operation Each patient will be placed in the lateral position with the site of injection uppermost. After skin disinfection and draping; screeningThe probe will be placed sagittal at the level of 6th rib in the posterior axillary line 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ASA I-II - scheduled for modified radical mastectomy. Patient refusal History of allergy to any of the injected drugs. Peripheral neuropathy Un-cooperative patient. Coagulopathy. Bilateral modified radical mastectomy patients or previous breast surgery. Infection at the site of injection. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 09/06/2021 Medical Research Institute Ethics Committee IORG0008812
Ethics Committee Address
Street address City Postal code Country
165 Horreya Avenus Hadara Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale VAS Every 4 hours for the first 24 hours postoperatively
Secondary Outcome Neuropathic pain DN4 scale After 1 week post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anesthesia and Surgical Intensive Care Medical Research Institute Alexandria University 165 Horreya Avenus Hadara Alexandria 21516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Bakinbam wagih 23 amir albihar street kafr abdo roushedy Alexandria 21111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 165 Horreya Avenus Hadara Alexandria 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Magda Abo Ollo 165 Horreya Avenus Hadara Alexandria 21516 Egypt
Adel Ibrahim Hassan Hozien 165 Horreya Avenus Hadara Alexandria 21516 Egypt
Wessam Alamrawy 165 Horreya Avenus Hadara Alexandria 21516 Egypt
Bakinam Wagih 23 amir albihar street Alexandria 21111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Magda AboOllo Magdaaboollo@hotmail.com 00201222220214 165 Horreya Avenus Hadara
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Anesthesia and Surgical Intensive Care Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Wessam Alamrawy Wesam_amrawy@yahoo.com 00201066062582 165 Horreya Avenus Hadara
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Lecturer of Anesthesia and Surgical Intensive Care 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