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.: PACTR202006770945823 Date of Approval: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Perineural versus IV dexmedetomidine with adductor canal block for perioperative analgesia in total knee arthroplasty; a randomized prospective controlled study
Official scientific title Perineural versus IV dexmedetomidine with adductor canal block for perioperative analgesia in total knee arthroplasty; a randomized prospective controlled study
Brief summary describing the background and objectives of the trial Introduction: There is an increase in the demand for arthroplasties especially hip and knee each year. Patients undergoing total knee arthroplasty (TKA) experience postoperative moderate to severe pain; prolonging hospital stay, affecting mobilization, non-compliance to physiotherapy, poor patients satisfaction, and an increase in analgesics intake with their many side effects.(1) The best pain management for TKA is a multimodal regimen, taking into consideration; systemic analgesics, local infiltration, adductor canal block (ACB), and femoral nerve block (FNB). Peripheral nerve blocks have been widely investigated for TKA with nearly comparable analgesic effect but less motor affection in favour of ACB versus FNB.(2) Different additives have been added to local anaesthetics used in ACB as; dexamethasone,(3) clonidine,(4) and dexmedetomidine,(5) these adjuvants were recorded to increase the duration of analgesia provided by ACB. Even in various studies intravenous dexmedetomidine(6) was found to be associated with a significant decrease in opioids use in the first 24 hr following TKA. Aim of the study: The primary aim of this study is to compare the duration of analgesia provided by ultrasound-guided adductor canal block (ACB) with either the addition of dexmedetomidine to the block or given intravenously (IV) intraoperatively in total knee replacement surgery. While, the secondary aims are; intraoperative and postoperative hemodynamics (MAP and HR), total analgesic (morphine) consumption, postoperative Ramsay sedation score, resting visual analogue scale (VAS), and dynamic VAS.
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: Drugs
Anticipated trial start date 01/09/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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 Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group P addactor canal block ACB total volume of 20 ml mixture (15 ml bupivacaine 0.5% + 5 ml saline containing dexmedetomidine 1µ/kg) 15 min ACB will be performed by a standard 22 gauge spinal quinke needle using a high-frequency (5–10MHz) ultrasound probe of ultrasound machine (Sonosite, Inc., Bothell, WA, USA), the probe will be placed at the mid-thigh (mid-way between anterior superior iliac spine and patella). After obtaining a cross-section view, the adductor canal will be found bounded by Sartorius muscle form above, vastus medialis muscle inferolateral, and adductor muscles inferomedial. The canal contains superficial femoral artery and vein with the saphenous nerve and nerve to vastus medialis lateral to the femoral artery.(7) The needle will be introduced from lateral to medial towards the nerves lateral to the artery, after reaching in proximity to the nerves inside the canal the 20 ml mixture solution will be injected. 50 Active-Treatment of Control Group
Experimental Group group I ACB with the administration of dexmedetomidine total volume of 20 ml mixture (15 ml bupivacaine 0.5% + 5 ml saline) with the administration of dexmedetomidine 1µ/kg/hr IV for an hour. 60 min ACB will be performed by a standard 22 gauge spinal quinke needle using a high-frequency (5–10MHz) ultrasound probe of ultrasound machine (Sonosite, Inc., Bothell, WA, USA), the probe will be placed at the mid-thigh (mid-way between anterior superior iliac spine and patella). After obtaining a cross-section view, the adductor canal will be found bounded by Sartorius muscle form above, vastus medialis muscle inferolateral, and adductor muscles inferomedial. The canal contains superficial femoral artery and vein with the saphenous nerve and nerve to vastus medialis lateral to the femoral artery.(7) The needle will be introduced from lateral to medial towards the nerves lateral to the artery, after reaching in proximity to the nerves inside the canal the 20 ml mixture solution will be injected, with the administration of dexmedetomidine 1µ/kg/hr IV for an hour. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists (ASA) physical status I or II Patient scheduled for total knee arthroplasty BMI > 35 kg/m2, pregnancy/lactation, any cardiac comorbidity, pre-existing neurological deficit, significant renal or hepatic impairment, severe pulmonary compromise, known contraindications to peripheral nerve block, allergies to local anaesthetic or dexmedetomidine, or chronic opioid users/abusers. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 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 20/02/2020 Ethics Committee Faculty of Medicine Alexandrea University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Alexandrea University, 17 Champllion st. Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare the duration of analgesia provided by ultrasound-guided adductor canal block (ACB) with either the addition of dexmedetomidine to the block or given intravenously (IV) intraoperatively in total knee replacement surgery. every 30 min till the completion of the surgery
Secondary Outcome Intraoperative and postoperative hemodynamics (MAP and HR), total analgesic (morphine) consumption, postoperative Ramsay sedation score, resting visual analogue scale (VAS), and dynamic VAS. every 30 min till the completion of the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospitals Khartoum square, Azaria Alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rabab Mahrous 33 Bahaa ElDin Elghatwary Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabab Mahrous 33 Bahaa ElDin Elgharwary, Smouha Alexandria 21526 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rabab Mahrous 33 Bahaa ElDin Elgharwary, Smouha Alexandria 21526 Egypt
Aly Mahmoud Mostafa Antoniades compound Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabab Mahrous roba98@hotmail.com 00201223497339 33 Bahaa eldin Elghatwary
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Assistant professor of Anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Aly Mostafa medical_all4one@hotmail.com 00201224129850 Antoniades Compound
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Amin Ahmed aminrazek@yahoo.com 0021227392464 33 Bahaa eldin Elghatwary
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor Faculty of Medicine Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Clinical Study Report 1 year open access
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