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.: PACTR201606001666108 Date of Approval: 07/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title adductor canal versus fascia iliaca block
Official scientific title Ultrasound-guided adductor canal block versus fascia iliaca compartment block for postoperative analgesia after arthroscopic knee surgery
Brief summary describing the background and objectives of the trial Arthroscopic knee surgery refers to a large variety of surgical interventions in the knee, and numerous analgesic regimens have been investigated in order to ¿nd the optimal combination of analgesics for these procedures The femoral nerve block has been the mainstay for postoperative pain treatment following knee replacement for decades. Current trends however, focus on providing analgesia with minimal motor block. Contrary to the femoral nerve block, the adductor canal block (ACB) is predominantly a sensory nerve block, preserving quadriceps muscle strength and mobilization ability. Fascia iliaca compartment block is an anterior thigh regional block of lumbar plexus, if local anesthetics injected posterior to the fascia iliaca, it diffuse in to its internal layers then to the femoral, lateral femoral cutaneous, genitofemoral, and obturator nerves which was later confirmed by radiography. The aim of the current study is to compare the effects of ultrasound guided adductor canal block versus ultrasound guided fascia iliaca compartment block for postoperative analgesia in patients undergoing arthroscopic knee surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,Postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/04/2016
Actual trial start date 17/05/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
30912/05/16 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality assurance unit
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 Permuted block randomisation Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound guided Adductor canal block group ( ACB ) 30 ml bupivacaine 0.25% Once Single injection 30
Experimental Group Ultrasound guided fascia iliaca compartment block : ( FICB ) 40 ml bupivacaine 0.25% Once Single injection 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 ¿ 40 years either gender ASA I-II undergoing elective arthroscopic knee surgery body mass index > 35 mental disorders any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality, or patient refusal) known allergy to the study drug pregnancy drug or alcohol abuse A daily intake of opioid analgesics. 18 Year(s) 40 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 16/05/2016 Tanta University, Faculty of Medicine, Research ethics committee, Quality assurance unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain. VAS 0 ( immediately after transport to PACU 2 h 4 h 6 h 12 h 24 h .
Secondary Outcome The quadriceps muscle power will be assessed with the patients (in the supine position) they will be asked to perform a straight leg raise. The motor block will be graded as follows: Grade 0, normal muscle power; grade I, motor weakness; grade II, complete motor paralysis 0 ( immediately after transport to PACU ) 2 h 4 h 6 h 12 h 24 h
Secondary Outcome Total consumption of rescue analgesia Once after 24 h post operative
Secondary Outcome Postoperative mean arterial blood pressure, heart rate 0 2 h 4 h 6 h 12 h 24 h
Secondary Outcome Any concomitant events like nausea; vomiting, shivering, pruritus or respiratory complications If occured
Secondary Outcome The overall patient satisfaction Once after 24 h postoperative
Secondary Outcome Neurological assessment Before hospital discharge After 3 weeks of surgery
Primary Outcome pain. VAS 0 ( immediately after transport to PACU 2 h 4 h 6 h 12 h 24 h .
Secondary Outcome The quadriceps muscle power will be assessed with the patients (in the supine position) they will be asked to perform a straight leg raise. The motor block will be graded as follows: Grade 0, normal muscle power; grade I, motor weakness; grade II, complete motor paralysis 0 ( immediately after transport to PACU ) 2 h 4 h 6 h 12 h 24 h
Secondary Outcome Total consumption of rescue analgesia Once after 24 h post operative
Secondary Outcome Postoperative mean arterial blood pressure, heart rate 0 2 h 4 h 6 h 12 h 24 h
Secondary Outcome Any concomitant events like nausea; vomiting, shivering, pruritus or respiratory complications If occured
Secondary Outcome The overall patient satisfaction Once after 24 h postoperative
Secondary Outcome Neurological assessment Before hospital discharge After 3 weeks of surgery
Secondary Outcome Time of first analgesic request When needed
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohamed Mohye Eldin Abu Elyazed 5 5 Stad street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb atreet
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information