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.: PACTR202307800477214 Date of Approval: 27/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Ultrasound-Guided Adductor Canal Block and Lateral Genicular Nerves Block versus Sole Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Comparative Trial
Official scientific title Combined Ultrasound-Guided Adductor Canal Block and Lateral Genicular Nerves Block versus Sole Adductor Canal Block in Anterior Cruciate Ligament Reconstruction: A Randomized Comparative Trial
Brief summary describing the background and objectives of the trial Postoperative pain after anterior cruciate ligament (ACL) reconstruction is moderate to severe in most patients. Thus, proper plane for pain management is important concern to improve both knee function and patient satisfaction. Femoral nerve block has gained popularity for being the gold standard technique for pain management following ACL reconstruction. Currently, there is a move to block the saphenous branch of the femoral nerve within the adductor canal (AC) due to the motor sparing properties at this location. Moreover, adductor canal block (ACB) has the advantage of providing additional analgesic properties over the saphenous nerve due to the presence of extrasensory branches from the obturator nerve supplying the knee, within the canal. ACB provides adequate analgesia at anteromedial aspect of knee; however, it has minimal or no effect on the posterior and lateral aspects of the knee. Thus, a hybrid block had been described to improve the analgesic properties of ACB. Genicular nerves are the main innervating articular branches for the knee joint. The superior medial genicular nerve (SMGN) and the inferior medial genicular nerve (IMGN) supply the medial and posterior aspect of knee joint while the superior lateral genicular never (SLGN) and inferior lateral genicular nerve (ILGN) supply the lateral and anterior aspect of knee joint. We speculate that addition of blockage of both SLGN and ILGN will improve the results of ACB, specifically at the lateral aspect of the knee in patients undergoing ACL reconstruction. This study aimed to assess the safety and efficacy of combined ultrasound-guided ACB plus LGNB compared to ACB alone in patients undergoing ACL reconstruction.
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 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 27/07/2023
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sole Adductor Canal Block 20 ml (10 ml of xylocaine 2% plus 10 ml of plain bupivacaine 0.5%) Before induction of general anesthesia Ultrasound-Guided Sole Adductor Canal Block in Anterior Cruciate Ligament by injection of 20ml (10 ml of xylocaine 2% plus 10 ml of plain bupivacaine 0.5%) 30 Active-Treatment of Control Group
Experimental Group Adductor Canal Block with Lateral Genicular Nerves Block 20 ml (10 ml of xylocaine 2% plus 10 ml of plain bupivacaine 0.5%) and 6 ml of xylocaine 2% Before induction of general anesthesia Patients received Ultrasound-Guided Adductor Canal Block and Lateral Genicular Nerves Block by injection of 20 ml (10 ml of xylocaine 2% plus 10 ml of plain bupivacaine 0.5%) and injection of 6 ml of xylocaine 2% at 2 separate target sites (the inferior lateral and superior medial genicular nerves) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing unilateral anterior cruciate ligament reconstruction under general anesthesia American Society of Anesthesiologists physical status I or II Age between 18 and 60 years old Patient refusal Operation done under neuraxial anesthesia Patients with coagulopathy (INR > 1.5) Patients having local infection at the site of injection Psychiatric patients who cannot comply with the study Previous surgery in the same knee Bilateral knee anterior cruciate ligament Patient sensitivity or allergy to any of the study drugs Adolescent: 13 Year-18 Year,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 21/03/2021 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment using visual analogue scale 2, 4, 6, 8, 12, 18, and 24 hours postoperatively during rest and movement
Secondary Outcome Time of first analgesic requirement During the first 24 hours postoperatively
Secondary Outcome Total dose of morphine required During the first 24 hours postoperatively
Secondary Outcome Number of required xylocaine boluses During the first 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Alainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Inas Kamel Ahmed Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Inas Ahmed inas.ahmed@mail.com 000000000000000 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries AbdelRahman Eidarous a.idarous2468@gmail.com 000000000000000 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Yahya Hammad res.train.1111@gmail.com +201114048081 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication On reasonable request the data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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