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.: PACTR202204720116048 Date of Approval: 28/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Different Patient Positions on ESPB for Modified Radical Mastectomy: RCT
Official scientific title Influence of Different Patient Positions on Erector Spinae Plane Block for Modified Radical Mastectomy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Breast cancer is the most common female cancer worldwide and modified radical mastectomy (MRM) is the most common surgical management. Multimodal perioperative analgesia is highly recommended for post breast surgery pain, it includes gabapentine, paracetamol ± non-steroidal anti-inflammatory drugs (NSAIDS), opioids, lidocaine based IV infusion and regional anaesthesia. Ultrasound guided Transthoracic facial plane blocks are novel methods to control perioperative pain, and it is comparable with paravertebral plane block. Erector spinae plane block (ESPB) is an interfascial plane block, first described in 2016 by Forero et al as an effective treatment for thoracic nociceptive and neuropathic pain. Its efficacy depends on the compartmental spread and the local anaesthetic (LA) distribution to nearby target nerves. The initial clinical findings suggested that ESPB injectant would spread to both the dorsal and ventral ramus of the spinal nerves, leading to blockage of both somatic and visceral pain. Cadaveric studies had been performed to assess the spread of dye in this novel block. However, not all of them have had extensive spread of dye. In one study, only minimal spread had been observed into the paravertebral space and in another it has been failed to demonstrate any spread at all into the paravertebral space or the ventral rami but there was extensive lateral and craniocaudal spread around the Erector Spinae (ES) complex.There are numerous factors affecting ESPB, among them is patient position, ESPB can be given in sitting, supine, and lateral decubitus positions; it is possible that the position of the patient when performing ESPB may affect the spread of local anaesthetic and thus the effect and quality of ESPB. To our knowledge no studies have examined this effect. The aim of this study is to evaluate the influence of patient lateral and sitting positions on the local anaesthetic spread into the erector spinea plane in patients undergoing unilateral modified r
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2022
Actual trial start date
Anticipated date of last follow up 31/10/2022
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 N/A
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sitting position 35 ml of 0.25% bupivacaine + 5 ml radiocontrast 30 minutes before surgery Using ultrasound guidance, ESPB will be given in sitting position 20
Control Group Lateral position 35 ml of 0.25% bupivacaine + 5 ml radiocontrast 30 minutes before surgery using ultrasound guidance, ESPB will be given in lateral position 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients ASA I and II Patients undergoing unilateral modified radical mastectomy under general anaesthesia Scoliosis or any vertebral anomalies or previous spinal surgeries. Morbid obesity (BMI ≥ 40). Allergy or contraindication to any of the studied medications. Chronic opioid use. Pregnancy. Infection at the site of injection, coagulopathy, or any other contraindication for regional anaesthesia. Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 19/08/2021 The Ethics Committee of the 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 Level of vertebral spread using CT 15 minutes after ESPB
Primary Outcome Level of dermatomal spread using cold sensation 20 minutes after ESPB
Secondary Outcome VAS score upon arrival from the operating room and then every 4 hours for the rest of the first 24 hours postoperatively.
Secondary Outcome Total morphine consumption for of the first 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery Department Medical research institute Alexanderia Uneversity 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Farouk Mohamed Elsosy 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hussein mohamed Agameya 17 champolllion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Sahar Ahmed Elkaradawy 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Mohamed mohamed Elnakeeb 17 champlion street elmesallah Alexandria 21521 Egypt
Adel ibrahim Hozein 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Walid mohamed ahmed 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Ahmed Faouk Elsosy 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hussein Agameya Hussein_agameya@yahoo.com 0020122218056 17 champolllion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Sahar Elkaradawy saharelkaradawy@yahoo.com 00201006627952 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anaesthesia and Pain Management Medical research Institute Alexandria University
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 an e-mail to elsayedamr@yahoo.com (public relations) 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