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.: PACTR202010699507804 Date of Registration: 12/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Rhomboid Intercostal And Subserratus Plane Block For Modified Radical Mastectomy
Official scientific title Ultrasound Guided Rhomboid Intercostal And Subserratus Plane Block For Postoperative Analgesia In Modified Radical Mastectomy. A Prospective Randomized Study
Brief summary describing the background and objectives of the trial Breast cancer is the most common cancer among women, and the incidence of breast cancer continues to rise. Acute postoperative pain is an integral risk factor in the development of chronic pain after breast cancer surgery (BCS). Ultrasound (US)-guided rhomboid intercostal and subserratus plane (RISS) block was first described by El sharkawy et al. in 2018. Authors suggested that injection of local anesthetic into the two tissue plane; between the rhomboid and intercostal muscles and deep to the scapula and serratus anterior muscle, consistently blocks the lateral cutaneous branches of the intercostal nerves and provided satisfactory postoperative analgesia after chest wall surgery
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: Other
Anticipated trial start date 28/10/2020
Actual trial start date
Anticipated date of last follow up 30/03/2021
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General Anesthesia Fentanyl 1µg, propofol 2mg/kg and cisatracurium 0.15 mg/kg IV once at induction once Anesthesia will be induced in all patients using Fentanyl 1µg, propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5‑2% in oxygen and air mixture, cisatracurium0.03 mg/kg. 20 Placebo
Experimental Group ultrasound guided rhomboid intercostal and subserratus block 30 ml of local anesthetic once The patient will be placed in a lateral decubitus position with site of operation uppermost. A linear ultrasound probe (6-12 MHz) will be placed in the sagittal plane medial to the medial border of the scapula at T4 level. The tissue plane between the rhomboid major and intercostals muscles identified, 80 mm, 22 G needle (B. Braun Medical Inc., Bethlehem, PA) advanced in plane, through the trapezius and rhomboid major muscles 10 ml of bupivacaine 0.25% will be injected in the fascial plane between the rhomboid major muscle and the intercostal muscles. To identify the subserratus plane, the probe moved caudally and laterally, distal to the inferior angle of the scapula behind the posterior axillary line. The needle inserted at the same skin entry site as was used for the rhomboid intercostal injection but directed caudally and laterally beyond the inferior angle of the scapula. 20 ml bupivacaine 0.25% injected in the tissue plane between the serratus anterior and external intercostal muscle. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Forty adult female patients aged 18-60 years old classified by the American society of anesthesiologists as ASA I and II Patients refusal spine or chest wall deformity coagulation disorders body mass index ≥35 chronic analgesic use, and known allergy to study drugs Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 07/09/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative analgesic requirement once with in 24 hours
Secondary Outcome first analgesic requirement and pain score first analgesic requirement will be measured once with in 24 hour and pain score will be measured within 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad El Geish Tanta 31527 Egypt
Dina Ahmed Ali El Malla El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor of Anesthesia Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mona El Mourad monamorad80@gmail.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor of Anesthesia Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Dina El Malla dr_dina90@yahoo.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1- Demographic data 3- total postoperative analgesic requirement in 24 hours 3- Pain score, pain will be assessed using the numerical rating scale (NRS), 4- Time for first need of analgesic Study Protocol 2 years to those who request the data via the email of the principal investigator according to the cause of request
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