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.: PACTR202307777479162 Date of Approval: 31/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine and Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique
Official scientific title The value of local dexmedetomidine as an adjuvant to Wide-Awake Local Anesthesia No Tourniquet (WALANT) anesthesia in flexor tendon repair
Brief summary describing the background and objectives of the trial Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique allows for intraoperative motor assessment of tendon repair integrity. No studies had evaluated the effect of adding dexmedetomidine for lidocaine on the analgesic properties of the WALANT technique. The aim of this study is to compare the WALANT technique with and without dexmedetomidine regarding the total morphine consumption throughout the 1st postoperative day as the primary outcome.
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: Surgery
Anticipated trial start date 30/04/2022
Actual trial start date 30/04/2022
Anticipated date of last follow up 02/08/2023
Actual Last follow-up date 15/11/2023
Anticipated target sample size (number of participants) 128
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 Simple randomization using a randomization table created by a computer software program 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 WALANT with dexmedetomidine Dexmedetomidine (1μg/kg) is injected with lidocaine for Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique for 24 hours follow up patients Will receive WALANT with dexmedetomidine. This injectate was prepared from 50 ml unrefrigerated lidocaine 1% (with a total infiltration dose < 7 mg/kg), 1ml epinephrine (1:1000) mixed with 50ml normal saline. Dexmedetomidine (1μg/kg) was added. 64
Control Group control group 20 ml lidocaine only was injected for 24 hours follow up patients will receive Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique 64 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients of both sex aged more than 20 years old, diagnosed with a flexor tendon injury in the hand region, scheduled for surgical intervention under WALANT, and classified as class I or II according to the American Society of Anesthesiologists (ASA) physical status score patients refusal of anesthesia technique, patients diagnosed with finger tendon lesions, bleeding diathesis, ASA class III or more, or had known allergies to any of the study medications patients with concomitant bony fractures or requiring digital nerve repair. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 80 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 20/04/2022 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total morphine consumption throughout the 1st post-operative day 1st post-operative 24 hours
Secondary Outcome time to first analgesic request for 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura university hospital 2 El-Gomhouria Street mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud Alseoudy drs3ody.mansora@mans.edu.eg +201006224551 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt mansoura university
Role Name Email Phone Street address
Public Enquiries Elsayed Abdelkarime elsayedabdelkarim@mans.edu.eg +201004965196 Gdela street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mai Elsherbeny mayelsherbiny@mans.edu.eg +201007193559 Ahmed maher street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that will be shared is the individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
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