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.: PACTR202407867061158 Date of Approval: 12/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound-Guided Femoro-Sciatic Nerve Block versus Hemispinal Anesthesia in Acute Lower Limb Ischemia: A Prospective Randomized Comparative Study
Official scientific title Ultrasound-Guided Femoro-Sciatic Nerve Block versus Hemispinal Anesthesia in Acute Lower Limb Ischemia: A Prospective Randomized Comparative Study
Brief summary describing the background and objectives of the trial Acute lower limb ischemia (ALLI) is a critical condition that requires prompt surgical intervention. The choice of anesthetic technique can have a significant impact on patient outcomes. This study aimed to compare the efficacy and safety of ultrasound-guided femoro-sciatic nerve block (FSNB) and hemispinal anesthesia (HSA) in patients undergoing surgery for acute lower limb ischemia. Hemi-spinal anesthesia (HSA) has been used successfully in high-risk patients undergoing surgery involving one lower limb. It has many advantages over conventional SA such as lower incidence of hypotension, faster recovery, and increased patient satisfaction. On the other hand, ultrasound-guided nerve blocks including ultrasound guided femoral-sciatic nerve block (FSNB), have been shown to decrease the block time while also reducing the time to onset of anesthesia, improve operator accuracy during the infiltration of anesthetic solutions, thereby increasing the overall success rates and block quality. In addition, us-guided nerve blocks require smaller quantities of anesthetic solutions to achieve the effect. These benefits ultimately improve patient safety
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2022
Actual trial start date 15/02/2022
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date 01/05/2024
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Femorosciatic nerve block group 15 ml mixture containing 10 ml of isobaric bupivacaine 0.5% and 5 ml of lignocaine 2% Bolus The femoral and sciatic nerves were identified using ultrasound guidance and blocked under complete aseptic technique. Femoral nerve block was performed with the patient in the supine position. With the patients on the same position, the hip was abducted, externally rotated, and the knee flexed until exposure of the calf and foot. The curved probe was placed perpendicular to skin approximately 8cm distal to the inguinal crease to identify the sciatic nerve. The sciatic nerve was visualized posterior and medial to the lesser trochanter of the femur. 22
Control Group Hemispinal anesthesia group 2ml of hyperbaric bupivacaine 0.5% and 10 mcg fentanyl Bolus Hemi-spinal anesthesia was performed with the patient placed in lateral position with the limb to be operated was in the dependent position with his/her knees tightly drawn up to his/her chest, Under a complete aseptic technique. 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA Ⅱ-Ⅲ, aged 30-70 years’ patients, of either sex were scheduled for surgery of acute lower limb ischemia uncooperative, refuse, unconscious, BMI ≥ 35 kg/ m², a known allergy to study drugs, previous femoral artery grafts or injuries were excluded from the study. Patients with contraindications to regional anesthesia, including severe coagulopathy, infection at the injection site, or neurological impairment. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 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 29/01/2022 Institutional Review Board.. Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Gomhoria street Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of sensory block intraoperative and postoperative
Secondary Outcome time to onset of sensory, motor blocks Duration of surgery, duration of motor block, intra-and post-operative hemodynamic ,the incidence of intraoperative and postoperative complications , consumed amount of intraoperative midazolam and fentanyl, total amount of intra- and post-operative analgesic drugsas well as VAS scoreat both rest and activity. intraoperative, before and immediately after the block, then every 15min in the first hour, every 30 mins the till end of surgery,then postoperative 30min, 60min, 2, 3, 4, 6, 12 and 24 hr
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic and Vascular Surgery Center of Mansoura university Gomhoria street Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek Habeeb Ramadan Al Gomhoria street Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Al Gomhoria street Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Sayed Ahmed Mohammed Elawady Al Gomhoria street Mansoura 35511 Egypt
Nehal Alaa ELDien Abbass Hamza Al Gomhoria street Mansoura 35511 Egypt
Hazem ELsayed Moawad Al Gomhoria street Mansoura 35511 Egypt
Mohammed Ahmed Ahmed Sultan Al Gomhoria street Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mostafa Elawady dr_tarekhabeeb@yahoo.com +01005663554 Al Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant Prof of Anesthesia and Surgical ICU
Role Name Email Phone Street address
Principal Investigator Tarek Habeeb Ramadan dr_tarekhabeeb@yahoo.com +01005663554 Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Anesthesia and Surgical ICU. Faculty of Medicine. Mansoura University
Role Name Email Phone Street address
Public Enquiries Hazem Moawad dr_tarekhabeeb@yahoo.com +01005663554 Al Gomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of Anesthesia and Surgical ICU. Faculty of Medicine. Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol from 6 month up to 48 months after article publication Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to dr_tarekhabeeb@yahoo.com. To gain access, data requestors will need to sign a data access agreement from the principle investigators.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.mans.edu.eg 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