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.: PACTR202110546411428 Date of Approval: 12/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesic Efficacy of Ultrasound Guided Erector Spinae Plain Block Versus Serratus Anterior Plain Block Using Bupivacaine-Dexamethasone for Patients Undergoing Modified Radical Mastectomy
Official scientific title Analgesic Efficacy of Ultrasound Guided Erector Spinae Plain Block Versus Serratus Anterior Plain Block Using Bupivacaine-Dexamethasone for Patients Undergoing Modified Radical Mastectomy
Brief summary describing the background and objectives of the trial this study is designed to compare Erector spinae block (ESPB) versus Serratus anterior plane block (SAPB) in providing effective analgesia for radical mastectomy patients.
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 comparison of the efficacy of the 2 blocks
Anticipated trial start date 15/12/2020
Actual trial start date 01/01/2021
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 01/07/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group serratus anterior plane block 30mg bubivacaine and 8mg dexamethasone 6months The SAPB targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax (Mayes J et al.,2016). These branches of the intercostal nerves, therefore, travel through the two potential spaces described above. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax (Blanco R et al.,2013). 20 Active-Treatment of Control Group
Experimental Group ESPB 30ml Bupivacaine + 8mg Dexamethasone 6m ESPB Fascial plane blocks are techniques used to manage pain, both in the perioperative period and in the treatment of chronic pain. In recent years, different types of fascial blocks have been described and there has been an increase in their clinical applications. The main advantages offered by these techniques include the ease of performing them, the analgesic efficacy, and the low risk of complications. One of the newest techniques that have been described recently is the erector spinae plane (ESP) block. It was first described by ( Forero et al ., 2017) for the treatment of chronic thoracic neuropathic pain and postoperative pain in thoracic surgery. Since then, many articles (Chin et al.,2017) , (Kwon et al.,2018) and (Altiparmak et al.,2019) have been published describing the application of the technique for a wide variety of clinical scenarios. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patient aged between 20 and 70 years of American Society of Anesthesiologists physical status (ASA) grades I to III undergoing elective unilateral modified radical mastectomy. 1. Patient refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies…) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at site of the block. 6. Known allergy to the study drugs. 7. Body Mass Index >40 Kg/m2. 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 15/09/2020 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
mansoura university mansoura 35555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to the first analgesic request in hours (duration of analgesia) was recorded.▪ 6M
Secondary Outcome while the secondary outcomeThe hemodynamics parameters including Heart rate (HR), Mean arterial pressure (MAP) and Peripheral capillary oxygen saturation (SpO2) were recorded basal, after skin incision, 15 min., 30min., then every 30min. intraoperatively. Then in PACU immediately then at 2, 4, 8, 12, 16 and 24 hours post-operatively in the ward. ▪ Intraoperative total fentanyl consumption. ▪ Visual analogue scale score would be recorded at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively at rest and movement (arm abduction). ▪ Total analgesics required in 24 h postoperatively: Fentanyl, paracetamol. ▪ Any adverse effects related to the regional anesthetic technique would be also documented such as hypotension and bradycardia, inadvertent spinal injection, neurological manifestations, epidural hematoma, intravascular injection ▪ Surgeon satisfaction confirming analgesia and procedures by Bajwa S et al (Bajwa S et al.,2014).  Excellent  Good  Fair  Poor ▪ patient satisfaction confirming analgesia and procedures by Bajwa S et al (Bajwa S et al.,2014).  extremely satisfied  satisfied  not satisfied 6M
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
oncology mansoura university centre meetgarrah mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ahmed Magdy Mohammed Hassan Meetgarrah Mansoura Egypt Mansoura 35555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor magdy meetgarrah mansoura 35555 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Alseoudy drs3ody.mansoura@mans.edu.eg 00201006224551 meetgarrah
City Postal code Country Position/Affiliation
mansoura 35555 Egypt DR
Role Name Email Phone Street address
Public Enquiries Mahmoud Alseoudy drs3oody.mansoura@mans.edu.eg 00201006224551 meetgarrah
City Postal code Country Position/Affiliation
mansoura 35555 Egypt DR
Role Name Email Phone Street address
Scientific Enquiries mahmoud alseoudy drs3oody.mansoura@mans.edu.eg 0020100664551 meetgarrah
City Postal code Country Position/Affiliation
mansora 35555 Egypt DR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results within the trial registration record will be shared within 12 month after completion of the study Informed Consent Form within 12 months we will provide individual participant data and share it through the pub med indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
google scholar 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