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.: PACTR202206562721111 Date of Approval: 23/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined Suprainguinal Fascia Iliaca Block and Femoral Branch of Genitofemoral Nerve Block for Femoro-popliteal Bypass Surgery
Official scientific title Efficacy of Combined Suprainguinal Fascia Iliaca Block and Femoral Branch of Genitofemoral Nerve Block for Femoro-popliteal Bypass Surgery: A Prospective Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Patients undergoing lower extremity vascular surgery present major challenge to anesthesiologist. Most of the patients may have severe coronary artery disease (CAD) with other systemic disorders, and are at high risk for perioperative complications. Although lower limb revascularization surgery is commonly conducted under general or central neuraxial anesthesia, peripheral regional anesthesia could be a good alternative, especially in patients with high risk cardiac dysfunction
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 13/07/2022
Actual trial start date
Anticipated date of last follow up 18/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General anesthesia fentanyl 2 mcg, propofol 2 mg/kg, and atracurium 0.15 mg/kg IV once Anesthesia will be induced in all patients using fentanyl 2 mcg, propofol 2 mg/kg, and atracurium 0.15 mg/kg IV to facilitate endotracheal intubation. Anesthesia will be maintained by atracurium 0.03 mg/kg and isoflurane 1.2 – 1.5 MAC in oxygen and air mixture. 30 Placebo
Experimental Group combined fascia iliaca and femoral nerve block of genitofemoral nerve 50 ml of local anesthetic once the patient in the supine position, For fascia iliaca block patient will receive 40 ml of of 0.25% bupivacaine under ultrasound guidance, The Femoral branch block of genitofemoral nerve will be performed in the same position with 10 ml of 0.25% bupivacaine 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients aged 40-70 years old, classified by the American society of anesthesiologists as ASA II, III and IV Patients' refusal infection at the block site coagulation disorders chronic analgesic use known allergy to study drugs. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 07/06/2022 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 postoperative analgesic consumption once within 24 hours
Secondary Outcome duration of analgesia once with in 24 hour
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
Faculty of Medicine 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
Mohamed Shebl Abdelghany El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Abdelghany shebl7000@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 Assistant Professor of Anesthesia Faculty of Medicine Tanta University
Role Name Email Phone Street address
Principal Investigator 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 individual participant data that underlie the results reported in article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
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