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.: PACTR202103747444806 Date of Approval: 05/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rhomboid Intercostal and Subserratus Plane Block in Epigastric Hernia
Official scientific title Rhomboid Intercostal and Subserratus Plane Block (RISS) in Epigastric Hernia: A Prospective Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Epigastric hernia repair is one of the most common type of hernia repair performed after inguinal hernia. It is often performed under general anesthesia (GA). However, it is associated with many side effect, such as postoperative nausea and vomiting. Acute post-operative pain is attributed to the trans abdominal sutures and helical tacks that are used to hold the mesh in place against the inner aspect of the abdominal wall
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 30/03/2021
Actual trial start date
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Genera Anesthesia Fentanyl 1µg, propofol 2mg/kg and atracurium 0.5 mg/kg IV once induction will be done using Fentanyl 1µg, propofol 2mg/kg and atracurium 0.5 mg/kg IV to facilitate endotracheal intubation, anaesthesia will be maintained with isoflurane1.5‑2% in oxygen and air mixture, atracurium 0.1 mg/kg. 30 Placebo
Experimental Group Rhomboid intercostal and subserratus plane block 30 ml local anesthetic once The patient will be placed in a lateral decubitus position. 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 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 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult 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, chronic analgesic use known allergy to study drugs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
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 20/02/2021 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 24 hours postoperative
Secondary Outcome time for first need of analgesic once with in 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish Tanta 31527 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
Dina Ahmed El Malla El Geish Tanta 31527 Egypt
Mona Blough El Mourad El Geish Tanta 31527 Egypt
Mohamed Shebl Abdelghany 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 Mohamed Abdelghany shebl7000@gmail.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
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 2- 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