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.: PACTR201709002506387 Date of Approval: 09/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound-Guided Adductor Canal Block for Treatment of Chronic Osteoarthritis Knee Pain
Official scientific title Ultrasound-Guided Adductor Canal Block for Treatment of Chronic Osteoarthritis Knee Pain: Randomized Double Blind Controlled Study
Brief summary describing the background and objectives of the trial The aim of the study is to evaluate the effect of using a mixture of local anesthetic and steroid to the sensory nerves in the sub-sartorial canal on chronic osteoarthritis knee pain . All patients with osteoarthritis knee pain presenting to our Pain Clinic and meeting the inclusion criteria will be randomly allocated into two groups: - Group A: Patients will receive adductor canal block using normal saline and this will serve as control group. - Group B: Patients in this group will receive adductor canal injection of Bupivacaine 0.25% combined with Triamcinolone 40 mg. All patients will receive a total volume of 20 mL injectate (38) and will continue their medical treatment after doing the block and till the end of the study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied knee osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2015
Actual trial start date 15/05/2017
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 19/07/2017
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 80
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 randomisation using a radomisation table created by a computer software program 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 adductor canal block adductor canal injection of Bupivacaine 0.25% combined with Triamcinolone 40 mg. after proper sterilization, we will advance a 20-gauge 90 mm length, Quincke spinal needle with the bevel facing upward and the needle filled with glucose 5% (for better needle visualization) towards the lateral boundary of the femoral artery (destination one) using an in-plane approach from lateral to medial ensuring that our needle tip can be seen at all times. Then we will withdraw our needle b 40
Control Group adductor canal block 20cc of normal saline 0.9% after proper sterilization, we will advance a 20-gauge 90 mm length, Quincke spinal needle with the bevel facing upward and the needle filled with glucose 5% (for better needle visualization) towards the lateral boundary of the femoral artery (destination one) using an in-plane approach from lateral to medial ensuring that our needle tip can be seen at all times. Then we will withdraw our needle b 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients with established clinical and radiological diagnosis of chronic osteoarthritis (OA) who failed to respond to multimodal medical treatment including a combination of systemic and topical nonsteroidal anti-inflammatory drugs (NSAIDs) and pregabalin. 2- Age > 50 year. 3- Female patients. 4- Unilateral or bilateral knee pain 1- Patient refusal. 2- Patients with coagulopathy. 3- Patients having local infection at the site of injection. 4-Patients who cannot comply with the use of VAS. 5-Psychiatric patients or patients on antipsychotic drugs. 50 Year(s) 80 Year(s) Female
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 23/04/2016 faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
kasr alainy cairo 1771 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - The frequency of responders to intervention in each of the four study groups at 2 weeks assessment time point. Response to intervention is defined as a 50% or greater decrease in the pain VAS or the WOMAC pain subscale according to a proposal of Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International after 2 weeks
Secondary Outcome - The severity of knee OA pain using (VAS). one hour, 6 hours and 24 hours, 1week, 2 weeks, 4 weeks 8 weeks, 12 weeks, and six months.
Secondary Outcome - Knee function will be assessed using the validated WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis) one hour, 1week, 4 weeks, 8 weeks, 12 weeks, and six months and to compare these data with the pre-block values.
Secondary Outcome - Quadriceps muscle strength and the time to unassisted ambulation and readiness for charge from the outpatient clinic. before and immediately after intervention
Secondary Outcome Patient¿s global assessment of improvement after 3 and 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pain clinic at faculty of medicine cairo university hopsitals el kasr elainy street, cairo. cairo 1771 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
anesthesia department faculty of medicine cairo university kasr alainy cairo 1771 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department faculty of medicine cairo university kasr alainy cairo 1771 Egypt University
COLLABORATORS
Name Street address City Postal code Country
bassant mohamed abdelhamid kasr alainy cairo 1771 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed AbdElraouf mohraouf1@gmail.com 00201144442033 kasr alainy
City Postal code Country Position/Affiliation
cairo 1771 Egypt head of pain unit faculty of medicine cairo university
Role Name Email Phone Street address
Public Enquiries ahmed elshall dr.ahmedelshall@gmail.com 00201002998841 kasr alainy
City Postal code Country Position/Affiliation
cairo 1771 Egypt asisstant lecturer of anesthesia at faculty of medicine cairo university
Role Name Email Phone Street address
Scientific Enquiries ahmed elshall dr.ahmedelshall@gmail.com 00201002998841 kasr alainy
City Postal code Country Position/Affiliation
cairo 1771 Egypt asisstant lecturer of anesthesia at faculty of medicine cairo university
REPORTING
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