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.: PACTR202203622468379 Date of Approval: 16/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between adductor canal block vs. femoral nerve block in patients undergoing arthroscopic anterior cruciate ligament reconstruction using levobupivacaine: a randomized controlled double-blind study
Official scientific title Comparative study between adductor canal block vs. femoral nerve block in patients undergoing arthroscopic anterior cruciate ligament reconstruction using levobupivacaine: a randomized controlled double-blind study
Brief summary describing the background and objectives of the trial ACLR (anterior cruciate ligament reconstruction) is a common orthopaedic surgery that is usually done as an outpatient procedure. Following ACLR, many analgesic regimens are widely used to manage postoperative pain. Regional anaesthesia has been proven to reduce unplanned hospital admissions, delay to discharge, and opioid administration when used to provide postoperative analgesia in the outpatient setting of ACLR. Adductor canal block (ACB) is becoming more popular because it is thought to preserve motor nerves better than FNB. The main objective of our study was to compare the efficacy of ultrasound guided adductor canal block versus femoral nerve block in postoperative analgesia, as well as their effect on quadriceps muscle strength.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/06/2019
Actual trial start date
Anticipated date of last follow up 02/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group femoral nerve block 20 ml 0.5% levobupivacaine single injection femoral nerve block: after disinfection of the skin with povidone-iodine, a high-frequency linear probe (6 to 13 MHz; SonoSite M-Turbo) was placed parallel and slightly distal to the inguinal crease and adjusted as needed to visualise the femoral nerve in short axis. The iliopsoas muscle, femoral artery, and vein were all detected. The femoral nerve was detected within a triangular hyperechoic area lateral to the femoral artery, superficial to the iliopsoas muscle and deep to the fascia iliaca. A 5-cm 22-gauge insulated needle (B. Braun Medical Inc., USA) was placed in plane with the ultrasound probe and advanced from lateral to medial until the needle tip was adjacent to the femoral artery. After negative aspiration, 20 ml 0.5 percent levobupivacaine was administered to produce a spread above the femoral nerve and below the fascia iliaca. An adhesive tape was placed in the adductor canal block location to simulate a real block procedure for ensuring patient blindness. 33 Active-Treatment of Control Group
Experimental Group adductor canal block 20ml 0.5% levobupivacaine single injection (adductor canal block): after sterilizing the skin with povidone-iodine, a high-frequency linear array transducer (6 to 13 MHz; SonoSite M-Turbo; SonoSiteTM, USA) was placed in a transverse plane on the medial side of the mid-thigh to visualise the sartorius muscle, the underlying pulsating femoral artery, and the non- pulsating vein. The femoral nerve’s saphenous branch is usually found between the sartorius muscle superiorly, the adductor muscles medially, and the vastus medialis laterally in a triangular hyperechoic area. An insulated 5-cm 22-gauge needle (B. Braun Medical Inc., USA) was put in plane with the ultrasound probe and advanced from lateral to medial until the needle tip was visualized between the femoral artery and the sartorius muscle. 20 ml of 0.5 percent levobupivacaine was administered after negative aspiration. An adhesive tape was placed in the femoral nerve location to simulate a real block procedure for ensuring patient blindness. 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients of ASA I or ASA II. 2) Age range between 18-50 years. 3) Patient scheduled for elective unilateral ACL reconstruction. 4) Body mass index < 35 kg/m2 or less. 1) Patient’s refusal. 2) Pregnancy 3) Significant psychiatric or mental disorders 4) Allergy to local anesthetics. 5) Baseline neuropathy or neurological deficits involving the lower extremities. 6) Patients with coagulopathy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 02/06/2019 the Research Ethics Committee of faculty of medicine at Ainshams university
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya, cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of pain using VAS in the first 24 hours postoperatively. Time to first analgesic request and total narcotic needs PACU and every 2 hour for the first 24 hour postoperative
Secondary Outcome straight leg raise PACU and 2 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 56 Ramsis St., Abbasseya, cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kholoud Shawady 6155 Sayed Hasaballh street elmokattam Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor kholoud bahaa Eldin AbdelMohsen ElShawady 6155 dr sayed hasballah street - el mokattam cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Gamal zaki gamalzaki@med.asu.edu.eg 01222401438 56, Ramsis St., El Abbasia -
City Postal code Country Position/Affiliation
cairo 11591 Egypt faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Dalia Elfawy daliamfawy@yahoo.com 20201006211702 56, Ramsis St., El Abbasia -
City Postal code Country Position/Affiliation
cairo 11591 Egypt faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Marwa Elfar marwaemam600@gmail.com 20201000205686 56, Ramsis St., El Abbasia -
City Postal code Country Position/Affiliation
cairo 11591 Egypt faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hatem Abdelhamid Hatemsabdelhamid@gmail.com 20201022068269 56, Ramsis St., El Abbasia -
City Postal code Country Position/Affiliation
cairo 11591 Egypt faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data collected in this study will be available to other researchers just after the publication of the study Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol just after publication of the study within 1 year open access of all data just after publication at journal of anaesthesia of Ain shams university
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 11/03/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/03/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information