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.: PACTR202006517094995 Date of Registration: 24/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Flexor tendon surgeries under local anesthesia
Official scientific title Use of wide awake local anesthesia no tourniquet (WALANT) in flexor tendon surgeries compared to wide awake local anesthesia initially applied tourniquet (WALAIAT)
Brief summary describing the background and objectives of the trial It has been a standard practice to obtain local or general anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been changed in recent years. Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery which is called wide awake local anesthesia no tourniquet (WALANT). This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table. Cost of treatment comes down (because of no anesthesia cost in this kind of surgery), and some of these surgeries can be done in a simpler operating setting, such as in a minor procedure room. They get to speak to their surgeon during the surgery. The surgeon can answer their questions and educate them on good postoperative care and activity as well as return-to-work instructions. After the surgery, they simply sit up, elevate their totally comfortable hand, and walk out to go home. They never get nausea or vomiting. They get no urinary retention or sedation-induced dizziness. Almost all studies described flexor tendon surgeries done under either general anesthesia with tourniquet application or local anesthesia without tourniquet. None of the studies in our hands proposed doing these surgeries under local anesthesia with tourniquet application. The aim of this study is to evaluate the success of our proposed new method of flexor tendon surgeries under local anesthesia with initially applied tourniquet (WALAIAT; Wide Awake Local Anesthesia Initially Applied Tourniquet) in comparison with the well-known one; Wide Awake Local Anesthesia No Tourniquet (WALANT) and assess their advantages and disadvantages.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/06/2020
Actual trial start date
Anticipated date of last follow up 01/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R.20.05.845 IRB faculty of medicine Mansoura 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group WALANT flexor tendon surgeries 8 months Mixture of local anesthesia with epinephrine will be prepared, hand sterilization and then anesthesia administration will be done. We will wait for 30 minutes till the epinephrine starts its action without tourniquet application. 15 Active-Treatment of Control Group
Experimental Group WALAIAT flexor tendon surgeries 8 months Mixture of local anesthesia with epinephrine will be prepared, hand sterilization and then anesthesia administration will be done. The tourniquet will be applied and the procedure will be started immediately. The tourniquet will be deflated once it becomes uncomfortable for the patient. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be included in this study if they have hand injury with flexor tendon problem in need for repair (at time of trauma) or reconstruction (secondary flexor tendon procedures) Agree to do the operation under local anesthesia. Patients who can’t withstand local anesthesia (young age) Patients who refuse doing the procedures under local anesthesia Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 02/06/2020 IRB faculty of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
Algomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pre-operative time, Success of completing the surgical procedure under local anesthesia with the patient able to move his fingers intra-operative before and immediately after the operation
Secondary Outcome The time the patient can withstand the tourniquet intra-operative, the range of motion of the operated fingers three months post-operative during the operation, three months post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
plastic surgery department Mansoura university Algomhoria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Elsaid Abdelshaheed Albostan street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Elsaid Abdelshaheed Albostan Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdelshaheed becheerful@hotmail.com 00201002874175 Albostan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of plastic surgery Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Khalil ahmedkhalil2009@gmail.com 01141340413 Algomhoria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of plastic surgery Mansoura university
Role Name Email Phone Street address
Public Enquiries Omar Shouman omar2008hb@yahoo.com 00201223164668 Algomhoria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt head of plastic surgery department Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age, sex, trauma Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years data can be obtained from the corresponding author upon reasonable requests
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