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.: PACTR202304775359949 Date of Registration: 19/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia after Knee Surgeries
Official scientific title Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia after Knee Surgeries
Brief summary describing the background and objectives of the trial The aim of this study was to assess the analgesic efficacy of combined intrathecal dexmedetomidine and adductor canal block in patients undergoing Total Knee Arthroplasty surgeries. As based on previous research it was found that addition of dexmedetomidine to spinal anesthesia achieved the best results in terms of hemodynamic stability throughout surgery and adductor canal block achieved ultimate post operative analgesia after surgery and allowed required early mobilization for patients. thus, we aim to test the efficacy of both techniques when added to spinal anesthesia for total knee arthroplasty surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Adductor Canal Block
Anticipated trial start date 15/01/2023
Actual trial start date
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MKSU5017 Faculty of Medicine, Kafr Elsheikh University
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined intrathecal Dexmedetomidine and Adductor Canal Block once once Adductor canal block (ACB) a relatively new peripheral nerve block introduced by Lund et al, used in patients undergoing orthopedic procedures. It affects the two largest sensory contributors from the femoral nerve to the knee; the saphenous nerve and the branch to the vastus medialis, and also the articular branches of the obturator nerve. Moreover, the block is distal to most of the efferent branches to the quadriceps muscle and therefore largely preserves its strength. Dexmedetomidine, is rapidly emerging as additive to spinal anesthesia, providing awake sedation without respiratory depression with stable hemodynamics and analgesia through a highly selective α2 agonist receptors activity which have antinociceptive actions for both somatic and visceral pain. 35
Control Group Spinal anesthesia once once Spinal anesthesia is preferred for anesthesia in patients undergoing surgeries of lower limbs unless there is any contraindication for spinal anesthesia. When hyperbaric bupivacaine 0.5% is used alone in spinal anesthesia, it might be of relatively short duration of action with the need for switching to general anesthesia if the surgical procedure exceeds the drug’s duration of action 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patient’s approval. • Age: 30 – 65years. • Sex: Both males and females. • Physical Status: American Society of Anesthesiologists (ASA) I & II. • Patient refusal • Age: >65 and <30 years. • Allergy to Dexmedetomidine, local anesthetics, systemic opioids and any of the drugs included in the multimodal perioperative pain protocol. • Revision surgery. • Patients with impaired kidney functions and coagulopathy. • Chronic pain syndromes and patients with chronic opioid use defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery. • BMI of 40 or more. • Physical Status: American Society of Anesthesiologists (ASA) III & IV. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 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 09/01/2023 Kafr Elsheikh University Faculty of Medicine Scientific Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El gish road Kafr Elsheikh 33512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale (VAS) Scale 6,12,24,48 hours at rest and 24,48 hours after mobilization
Secondary Outcome 1. Time to first rescue analgesia. 2. Total Morphine consumption in the first 24 hours. 3. Anesthetic complications 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Kafr Elsheikh University El gish road Kafr Elsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
islam abousharkh street number 15 Elzohor district zagazig Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Kafr Elsheikh University El gish road Kafr Elsheikh Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator islam abousharkh islam.mnm@gmail.com +201000107726 street number 15 El zohor district
City Postal code Country Position/Affiliation
zagazig Egypt Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com +201005714014 Tanta
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Mohammad Algyar dr.mohamedfouad78@gmail.com +201111645345 Tanta
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, methodology report, individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) and including data dictionaries, summaries of results and discussion and recommendations, all will be shared upon the completion of study and publication of results. Data will be made available starting 6 months after study completion and for 30 months duration . Data will be shared with investigators who propose the use of this data has been approved by an independent review committee identified for that purpose. Data can be used for individual participants meta analysis or for further agreed upon scientific research purposes. Requests for sharing can be made starting 6 months after article publication to islam.mnm@gmail.com Link to results will be available upon the trial completion and at our university scientific research unit database. Clinical Study Report,Informed Consent Form,Study Protocol December 2023 to December 2025 Controlled
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