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.: PACTR202407490456486 Date of Approval: 23/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title WALANT versus brachial plexus Block for Distal Radius Fracture Fixation
Official scientific title Wide Awake Local Anesthesia without Tourniquet (WALANT) versus Supraclavicular brachial plexus Block for Distal Radius Fracture Fixation: A non-inferiority trial
Brief summary describing the background and objectives of the trial Background: Distal radial fractures are frequently encountered in both the emergency department and operating room settings, accounting for 8-15% of all bony injuries in adults . Distal radius fractures could be performed under general or regional anesthesia like the supraclavicular nerve block (SNB). However, the latter modality has some risks, including pneumothorax, Horner syndrome, and hemidiaphragmatic paralysis. The use of ultrasound guidance for the supraclavicular nerve block has significantly improved the safety margin and the quality of the block and has shortened the time taken to perform the block. The use of a tourniquet for hemostatic effect has been popular in simple hand surgeries, such as tendon repair or transfer, transverse carpal ligament release, and full-thickness skin grafts. However, the patients could not tolerate very long operation time in other long surgeries as distal radius fracture fixation because of tourniquet pain. Prolonged tourniquet usage may give rise to nerve injury or severe neurological deficit. Thus, a "wide-awake local anesthesia with no tourniquet" (WALANT) procedure was developed .The WALANT technique has been described in multiple orthopedic procedures in the upper limb with advantage of long time anesthesia and hemostatic effect. Dexmedetomidine is a highly selective drug α2-adrenergic receptor agonist. Dexmedetomidine has the characteristics of sedation, analgesia, anti-anxiety, inhibition of sympathetic activity, mild respiratory inhibition, and stable hemodynamics. Numerous studies have revealed that dexmedetomidine in peripheral nerve blocks can shorten the onset time of anesthesia and prolong the time of sensory and motor nerve blocks. It significantly improves the analgesic quality of WALANT when added to lidocaine with less opioid consumption . However, data comparing it to SNB is scarce. Herein, we compared SNB to WALANT in patients undergoing surgical fixation for distal radius fracture
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/07/2024
Actual trial start date
Anticipated date of last follow up 30/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wide Awake Local Anesthesia without Tourniquet In WALANT group, the injectate formed of 40 ml of freshly prepared 1% lidocaine (not exceeding 7 mg/kg) and 1:100,000 epinephrine, mixed with dexmedetomidine in a dose of 1 μg/kg. It is ideal to allow the local anesthesia a duration of at least 30 minutes to take effect. In WALANT group, the injectate formed of 40 ml of freshly prepared 1% lidocaine (not exceeding 7 mg/kg) and 1:100,000 epinephrine, mixed with dexmedetomidine in a dose of 1 μg/kg. The WALANT technique started with a total of 10 mL of subcutaneous local anesthesia is infiltrated using a 27-gauge needle along the modified Henry skin incision. We make sure to have at least 1 cm of visible or palpable subcutaneous local anesthetic proximal and distal to the site of the planned incision. Subsequently, another layer of local anesthesia is given under the periosteum in 3 injection points, to obtain a desired effect of painless surgery during reduction and plating of the distal radius fracture. We inject the solution using a 23-gauge needle at the radial border of the radius where it is easily palpable. A total of 30 mL of local anesthesia is used starting proximally with 10 mL in each injection site. It is ideal to allow the local anesthesia a duration of at least 30 minutes to take effect. It takes an average of 25 minutes for maximal cutaneous vasoconstriction to occur with 1:100,000 epinephrine 75
Control Group Supraclavicular brachial plexus Block In SCB group, the injectate is 32 ml of freshly prepared 1.5% lidocaine (not exceeding 7 mg/kg) with epinephrine 5 μg/mL, mixed with dexmedetomidine in a dose of 1 μg/k It is ideal to allow the local anesthesia a duration of at least 30 minutes to take effect. In SCB group, the injectate is 32 ml of freshly prepared 1.5% lidocaine (not exceeding 7 mg/kg) with epinephrine 5 μg/mL, mixed with dexmedetomidine in a dose of 1 μg/kg. The patient is placed in the supine position with arms by the sides. The head is turned towards the contralateral side of the block. Consider elevating the head of the bed about 30 degrees. A towel roll may be needed under the ipsilateral shoulder to improve access to supraclavicular space. Mild sedation may be provided (typically 1 to 2 mg of midazolam through an IV), though some patients may not require sedation. Aseptic technique is employed. Chlorhexidine gluconate 2% or povidone-iodine solution is applied to the skin. Sterile conduction gel is applied to the ultrasound probe, and the use of a sterile probe cover is recommended [11]. The ultrasound probe is applied in a sterile fashion in the supraclavicular fossa to obtain a short-axis view of the subclavian artery and the neural clusters. A skin wheal is raised with 3 mL lidocaine 1%. Using an in-plane technique and a lateral to medial direction, the block needle is initially advanced until its tip is positioned at the intersection of the first rib and subclavian artery (corner pocket). Half the volume (16 mL) of lidocaine 1.5% with epinephrine 5 μg/mL is injected in this location. Subsequently, the needle is redirected toward the main (largest) neural cluster, where the remaining volume (16 mL) of lidocaine is deposited. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- both sex aged 18-75 years old, - diagnosed with distal radius fracture, scheduled for surgical fixation (volar plating), and - classified as class I , II and III according to the American Society of Anesthesiologists (ASA) physical status score. - polytrauma patients - patients refusing regional anesthesia - bleeding diathesis, needle phobia, anxiety, peripheral vascular disease - known hypersensitivity to any of the study medication. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 19/05/2024 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 primary outcome will be is the success of the block (conduction of surgery with either techniques) without need to add sedative drugs or shift to general anesthesia. Time of surgery conduction, around 2 hours
Secondary Outcome Total morphine consumption first postoperative 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.mansoura@mans.edu.eg +201006224551 Abdelsalam Aref street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Mansoura university faculty of medicine
Role Name Email Phone Street address
Public Enquiries May Badr mayelsherbiny@mans.edu.eg +201007193959 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Mansoura university faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled nour kk_nour@yahoo.com +201007193959 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura Mansoura 35516 Egypt Mansoura university faculty of medicine
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) Informed Consent Form,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