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.: PACTR202309889843982 Date of Approval: 26/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between the analgesic efficacy of pectoralis major block II VS erector spinae blocks VS paravertebral blocks in postoperative analgesia in Modified Radical Mastectomy
Official scientific title Comparative study between the analgesic efficacy of pectoralis major block II VS erector spinae blocks VS paravertebral blocks in postoperative analgesia in Modified Radical Mastectomy
Brief summary describing the background and objectives of the trial Modified radical mastectomy surgery is frequently associated with significant pain in the immediate and persistent postsurgical pain. So, strategies to minimize acute postoperative pain after modified radical mastectomy surgery with multimodal analgesic regimens and regional anaesthetic techniques have been increasingly investigated and implemented. Procedures involving the chest wall and thoracic region are associated with poorly tolerated acute pain and may predispose patients to pathophysiological changes associated with the development of chronic postsurgical pain. So many regional blocks are developed for postoperative analgesia for modified radical mastectomy surgery. One such analgesic method for surgical procedures of the breast is the thoracic paravertebral nerve block (PVNB), which decreases pain and opioid consumption in both the immediate and remote postoperative periods. The erector spinae plane block (ESPB) is the most recently described of the fascial plane blocks performed for modified radical mastectomy surgery analgesia. The ESPB involves deposition of local anaesthetic deep to the erector spinae muscle and superficial to the transverse process and paravertebral space. Pectoralis major block I (PECS I) and Pectoralis Major Block II (PECS II) are interfascial plane blocks first described as recently as 2012. PECS I allows blockage of the medial and lateral pectoral nerves, whilst the PECS II block targets the lateral branch of the intercostal nerve; other nerves blocked include the intercostobrachial and long thoracic nerves. PECS II allows blockade of the axilla and intercostal nerves, which permits a wider area of surgical incision to be covered. The aim of this study is to compare between the analgesic efficacy of PECs block, paravertebral and erector spinae block in postoperative analgesia in modified radical mastectomy as regard pain scores and morphine consumption postoperatively.
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 Rehabilitation
Anticipated trial start date 03/11/2021
Actual trial start date 03/11/2021
Anticipated date of last follow up 02/11/2022
Actual Last follow-up date 02/11/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Completed
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PECS II BLOCK bupivacaine 0.25% 20 ml injected after operation completed. different chest wall blocks will be done after completing of surgery to compare between there efficacy. 50
Experimental Group Erector spinae group bupivacaine 0.25% 20 ml after completion of surgery injecting the local anaesthetic by ultrasound guidance 50
Experimental Group Paravertebral block bupivacaine 0.25% 20 ml after completion of surgery local anesthitec is injected in paravertebral space ultrasoud guided 50
Control Group no injection no medication null no intervention 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients undergoing modified radical mastectomy. • ASA physical status I to II • Sex (females) • Age 30-70 years. • Hypersensitivity to local anesthetics. • Infection near site of infections • Patient refusal. • Coagulopathy, use of anticoagulants or antiplatelets. Middle Aged: 45 Year(s)-64 Year(s) 30 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 02/11/2021 Research Ethics Committee at faculty of medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia square next to AlNour mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score 2 hours,4,6,12,24 hours
Secondary Outcome morphine consumption , sensory blockage and duration of blockage 2, 4,6,12,24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ainshams university 38 Abbassia Square Next to Al-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator 21 EL Shiek Mohamed Refat ,Heliopolis Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University 38 Abbassia Square next to El-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nancy Raouf 21 El-Shiek Mohammed Refaat, Heliopolis Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nancy Nawar nancy_raouf1@hotmail.com 00201001023246 21 El Shiek Mohamed Refaat Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer Department of Anaesthesia Faculty of medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Gehan Fouad gehan_fouad@med.asu.edu.eg 00201006616999 fifth settlment
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anethesia Faculty of medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries ramy mahrose ramy_mahrose@med.asu.edu.eg 00201281431097 Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Anaesthesia faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Osama Ramzy Osama_ramzy@med.asu.edu.eg 00201001429707 Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Anesthesia Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial after deidentification. Study Protocol Following publication Any purpose
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