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.: PACTR202110830502351 Date of Approval: 12/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative study between ultrasound guided four in one block versus femoral nerve block versus adductor canal block in enhanced recovery after knee replacement surgery
Official scientific title A Comparative study between ultrasound guided 4-in-1 block versus femoral nerve block versus adductor canal block in enhanced recovery after knee replacement surgery
Brief summary describing the background and objectives of the trial Enhanced recoveries after total knee replacement surgeries are gaining popularity in orthopedic surgeries. Motor preservation with adequate analgesia has become the optimal postoperative goal enabling earlier physical therapy, faster recovery, and early hospital discharge. Aim of this study is to compare the effect of 4-in-1 block versus femoral nerve block versus adductor canal block regarding pain control and early ambulation after knee replacement 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 16/02/2020
Actual trial start date 27/02/2020
Anticipated date of last follow up 16/02/2022
Actual Last follow-up date 14/08/2021
Anticipated target sample size (number of participants) 93
Actual target sample size (number of participants) 93
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 4in1 block 35 ml of bupivacaine 0.2% 24 hours The 4-in-1 block: Patients kept in supine position, with the ipsilateral limb kept in Frog leg position. The medial femoral condyle was marked. Under aseptic precautions, the linear transducer of ultrasound system placed over the femoral condyle and vastus medialis muscle and the Vastus and Sartorius intersection (anteromedial intermuscular septum) was identified and the transducer was slid proximally till the superficial femoral artery appeared in the Adductor Hiatus. Then slid proximally till the descending genicular artery branching from superficial femoral artery was visualized in the hiatus. This point was the injection point. The point was 8-10 cm above the femoral condyle. The needle used for the block will be an echogenic needle of 22 Gauge and 4 inches. Once the perivascular region reached, the needle will be inserted in-plane in a lateral to medial orientation under ultrasound guidance to reach perivascular region. A volume of 30 – 35 mL of 0.2% bupivacaine will be injected after negative aspiration to avoid accidental intravascular injection, and spread of drug solution will be visualized to push the femoral artery posteriorly. 31 Active-Treatment of Control Group
Experimental Group femoral nerve block 15 ml of bupivacaine 0.2% 24 hours The femoral nerve block: Patients kept in supine position, with the ipsilateral limb abducted 10-20 degrees and slightly externally rotated with the lateral side of the foot resting on the table. Under aseptic precautions, the linear transducer of ultrasound system placed on the femoral crease to obtain the images of the femoral nerve & artery. Before proceeding, skin infiltration with local anesthetic will be done using a 5ml syringe containing 5ml of 1% lidocaine. The needle used for the block will be an echogenic needle of 22 Gauge and 4 inches. Once the femoral nerve is visualized, the needle will be inserted in-plane in a lateral to medial orientation and advanced toward the nerve. A volume of 10-15mL of 0.2% bupivacaine will be administered around the femoral nerve after negative aspiration to avoid accidental intravascular injection, and spread of drug solution will be observed in tissue planes under ultrasound imaging. 31
Experimental Group adductor canal block 15 ml of bupivacaine 0.2% 24 hours The adductor canal block: Patients kept in supine position, with the thigh abducted and externally rotated to allow access to the medial thigh. Under aseptic precautions, the linear transducer of ultrasound system placed horizontally at the mid-thigh level (approximately halfway between the anterior superior iliac spine and the patella). Before proceeding, skin infiltration with local anesthesia will be done using a 5ml syringe containing 5ml of 1% lidocaine. The needle used for the block will be an echogenic needle of 22 Gauge and 4 inches. Once the saphenous nerve, femoral artery and vein identified. The needle will be inserted in-plane, till its tip becomes just anterior to the femoral artery, deep to the Sartorius muscle. A volume of 10-15mL of 0.2% bupivacaine will be injected after negative aspiration to avoid accidental intravascular injection, and spread of drug solution will be observed in tissue planes under ultrasound imaging. 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of American Society of Anesthesiologists (ASA) physical status I to III of both genders, ≥ 21 to 65 years, scheduled for elective knee replacement surgeries. Non-ambulatory/bed ridden patients. Patients with clinically significant coagulopathy. Infection at the injection site. Allergy to local anesthetics. Polytrauma patients having lower limb fractures. Patients with pre-existing myopathy or neuropathy on the operating limb. Patients with significant cognitive dysfunction. Chronic analgesic abuser patients. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 16/02/2020 Research Ethics Committee at Faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbasseya, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post operative pain control, measured using VAS score after 2. 4. 8 . 12 . 16 . 24 hours
Secondary Outcome Postoperative Quadriceps muscle strength, as indicator of functional recovery, using straight leg raise test and time up and go test after 24 hours
Secondary Outcome Total cumulative dose of narcotics after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 56, Ramsis St., El Abbasia - Cairo - Egypt Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams university educational Hospitals 56, Ramsis St., El Abbasia - Cairo - Egypt Cairo 11517 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals 56, Ramsis St., El Abbasia - Cairo - Egypt Cairo 11517 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Galal Adel Mohamed El Kadi 56, Ramsis St., El Abbasia - Cairo - Egypt Cairo 11517 Egypt
Mohamed Mohsen Mohamed 56, Ramsis St., El Abbasia - Cairo - Egypt Cairo 11517 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator islam mostafa islammostafa@med.asu.edu.eg 00201064565674 Shubra - Cairo - Egypt
City Postal code Country Position/Affiliation
Cairo 11672 Egypt assistant lecturer of anesthesia intensive care and pain management Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Gala El Kadi GalalElkadi@med.asu.edu.eg 00201066474183 56, Ramsis St., El Abbasia - Cairo - Egypt
City Postal code Country Position/Affiliation
Cairo 11517 Egypt Professor of anesthesia intensive care pain management Ain shams university
Role Name Email Phone Street address
Public Enquiries Mohamed Mohsen MohamdMohsen@med.asu.edu.eg 00201204227780 56, Ramsis St., El Abbasia - Cairo - Egypt
City Postal code Country Position/Affiliation
Cairo 11517 Egypt lecturer of anesthesia intensive care pain management Ain sham university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 07/10/2021
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