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.: PACTR201703002096249 Date of Approval: 13/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adductor canal block (ACB) versus ACB and distal ( intermuscular) saphenous nerve block
Official scientific title Adductor canal block (ACB) versus ACB and distal ( intermuscular) saphenous nerve block after ACL under GA: RCT
Brief summary describing the background and objectives of the trial We hypothesis that blocking the saphenous nerve in the distal third of thigh (after leaving the adductor hiatus) can compensate for any patchy (incomplete) block of saphenous nerve within the adductor canal during ACB. Thus, addition of saphenous nerve block in the distal third of thigh to ACB probably will lead to a more reliable and more successful results and may be a more prolonged compared to ACB alone. Aim of the study: To compare the efficacy of the ACB to the efficacy of combined ACB and saphenous nerve block at the distal third of thigh in the intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following knee arthroscopic ACL repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Musculoskeletal Diseases,post operative pain management after total knee replacement,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 13/03/2017
Actual trial start date 13/03/2017
Anticipated date of last follow up 22/03/2017
Actual Last follow-up date 22/03/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
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 randomisation using a radomisation table created by a computer software program Randomization was performed by computer generated randomization sequence (www.randomizer.org) in pre-prepared opaque envelopes. Sensory and motor block assessments were Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ACB and distal ( intermuscular) saphenous nerve block 20 ml local anesthetic (10ml bupivacaine 0.5%+10ml lidocaine 2%) for ACB,10 mL (5ml bupivacaine 0.5%+5ml lidocaine 2%) for SNB regonal anesthesia for post operative pain managment 25
Control Group ACB 20 ml local anesthetic (10ml bupivacaine 0.5%+10ml lidocaine 2% Regonal anesthesia for post operative pain managment 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients age from 18-60 body mass index (BMI) <30 kg/m2 scheduled for knee orthopedic ( ACL repair) surgery Patients younger than 18 years or older than 60 years allergy to local anesthetics bleeding disorders Glasgow Coma Scale <15 pregnancy neurologic deficits 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
No 13/03/2017 facuty of medicine cairo univercity
Ethics Committee Address
Street address City Postal code Country
kasr alainy cairo Egypt
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 13/03/2017 elasema hospital
Ethics Committee Address
Street address City Postal code Country
elahrar hospital eldokki elgiza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative VAS immediate post operative
Secondary Outcome o Onset (time from onset of block till occurrence of pain). 2, 4, 8, and 24 post-operatively. Recordings made at these time, pain at rest, and pain during 45 degrees flexion of the knee.
Secondary Outcome severity and distribution of pain 2, 4, 8, and 24 post-operatively. Recordings made at these time, pain at rest, and pain during 45 degrees flexion of the knee.
Secondary Outcome Post operative opioid consumption. 2, 4, 8, and 24 post-operatively. Recordings made at these time, pain at rest, and pain during 45 degrees flexion of the knee.
Secondary Outcome incidence of complications (vascular puncture, and presence or absence of saphenous nerve neuritis) for vascular puncture: during the intervention for saphenous neuritis:during the first month after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elasema hospital elahrar street giza Egypt
faculty of medicine cairo univercity kasr elainy cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine kasr elainy cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine kasr elainy cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
facuty of medicine kasr elainy cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed abdelraof mohraouf1@gmail.com o1223117933 kasr alainy
City Postal code Country Position/Affiliation
cairo Egypt professor of anesthesia faculty of medicine cairo univesity
Role Name Email Phone Street address
Principal Investigator bassant abdelhamid bassantmohamed197@yahoo.com o1224254012 kasralainy
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia faculty of medicine cairo university
Role Name Email Phone Street address
Public Enquiries bassant abd elhamid bassantmohamed197@yahoo.com 01224254012 kasr alainy
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia faculty of medicine cairo university
Role Name Email Phone Street address
Scientific Enquiries bassant abd elhamid bassantmohamed197@yahoo.com 01224254012 kasr alainy
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia faculty of medicine cairo university
REPORTING
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