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.: Date of Approval: 17/11/2022
Trial Status: Dormant - There has been no activity on this trial for six months or more
TRIAL DESCRIPTION
Public title The Value of Local Dexmedetomidine as an Adjuvant to WALANT Anesthesia in Flexor Tendon Repair Surgeries
Official scientific title The Value of Local Dexmedetomidine as an Adjuvant to WALANT Anesthesia in Flexor Tendon Repair Surgeries
Brief summary describing the background and objectives of the trial Flexor tendon injuries of the hand could be repaired under general or local anaesthesia. Local anaesthesia allows intraoperative motor testing to assess the repair integrity. The “Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique” has been widely applied in hand and wrist lesions. However, the administered local anaesthetic is short-acting and post-operative analgesia is usually inadequate. We hypothesized that adding dexmedetomidine should improve the analgesic properties of WALANT in patients undergoing flexor tendon repair. Patients and methods: This prospective investigation included 128 patients who underwent surgery for flexor tendon injury. They were divided into two groups; Group D received WALANT plus dexmedetomidine, and Group C received only WALANT.
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 anesthetic techniques
Anticipated trial start date 20/11/2022
Actual trial start date 25/11/2022
Anticipated date of last follow up 25/01/2023
Actual Last follow-up date 30/01/2023
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group C group This injectate will include unrefrigerated lidocaine 1% (with a total infiltration dose < 7 mg/kg), in addition to epinephrine (1:100000). For both groups, the injectate will be installed in the waiting area 30 minutes before surgery. Along with basal pulse and MAP readings, these variables will be measured at 10, 20, 30, 45, and 60 minutes after WALANT application This injectate will include unrefrigerated lidocaine 1% (with a total infiltration dose < 7 mg/kg), in addition to epinephrine (1:100000). We mainly depend on median/ulnar nerve block in these cases. The block will be started by subcutaneous injecting 2 ml of the injectate at a point 2 – 4 cm proximal to the wrist joint. This is followed by an 8 ml injectate under the forearm fascia. After that, about 20 ml of the same injectate will be installed into the palm, 10 ml over the carpal tunnel region, and 10 ml over the distal palm region. 2 ml will be injected under the skin of the proximal phalanges. If the middle phalanx needed exposure, an additional 2 ml will be injected. After tendon repair, it will be tested with active flexion and full extension before skin closure. 64 Placebo
Experimental Group group D unrefrigerated lidocaine 1% (with a total infiltration dose < 7 mg/kg), in addition to epinephrine (1:100000). Dexmedetomidine (1 µ/kg) was added For both groups, the injectate will be installed in the waiting area 30 minutes before surgery. Along with basal pulse and MAP readings, these variables will be measured at 10, 20, 30, 45, and 60 minutes after WALANT application. This injectate will include unrefrigerated lidocaine 1% (with a total infiltration dose < 7 mg/kg), in addition to epinephrine (1:100000). Dexmedetomidine (1 µ/kg) was added for Group D. We mainly depend on median/ulnar nerve block in these cases. The block will be started by subcutaneous injecting 2 ml of the injectate at a point 2 – 4 cm proximal to the wrist joint. This is followed by an 8 ml injectate under the forearm fascia. After that, about 20 ml of the same injectate will be installed into the palm, 10 ml over the carpal tunnel region, and 10 ml over the distal palm region. 2 ml will be injected under the skin of the proximal phalanges. If the middle phalanx needed exposure, an additional 2 ml will be injected. After tendon repair, it will be tested with active flexion and full extension before skin closure. 64
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients 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) Patients have bleeding diathesis, ASA class III or more, patients have known allergies to any of the study medications. patients with concomitant bony fractures or requiring digital nerve repair. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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
Yes 20/04/2022 Medical Research Ethics Committee Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board IRB office building A-Ground floor-Faculty of Medicine-Mansoura University Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total morphine consumption throughout the 1st post-operative day 24 hours
Secondary Outcome pain score, duration of sensory blockade, time to first analgesic request, number of patients requiring rescue analgesia, and patient satisfaction. 24 HOURS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Mansoura University Algomhoria street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university hospitals Algomhoria street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor May E Badr Algomhoria street Mansoura Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Abdelkarime elsayedabdelkarime@gmail.com 96569927828 algomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries May Badr mayelsherbiny@mans.edu.eg 201007193959 algomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt lecturer
Role Name Email Phone Street address
Public Enquiries khaled nour kk_nour@yahoo.com 201003660657 algomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification( text, tables, figures, and appendices). Study Protocol beginning 9 months and ending 36 months following article publication controlled access for individual participant data meta-analysis
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