Hand Surgery, Local Infiltration
Conditions
Keywords
WALANT, Wide-Awake, Hand surgery, Hyaluronidase
Brief summary
The WALANT (Wide Awake Local Anesthesia No Tourniquet) method, introduced by Dr. Donald H. Lalonde over a decade ago, has gained popularity due to its favorable outcomes and patient satisfaction. This technique involves injecting diluted lidocaine and epinephrine, which helps control pain and bleeding without the discomfort of a tourniquet. This research will explore the use of hyaluronidase to enhance the WALANT technique. The study hypothesize that adding hyaluronidase would improve the onset speed and duration of pain control. A double-blinded study involving 100 patients compared WALANT with hyaluronidase (Group A) to WALANT without Hyaluronidase (Group B).
Detailed description
Background: Hand surgery, being one of the most frequent outpatient procedures, remains undecided regarding the ideal anesthesia technique. Wide-Awake Local Anesthesia No Tourniquet (WALANT) is one of the frequently used anesthesia techniques by some hand surgeons (8%). Objective: The study aims to evaluate the impact of hyaluronidase administration on the onset and persistence of WALANT in hand surgery. Patients and Methods: This Prospective, randomized, double-blind clinical trial will be conducted in Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST). One hundred patients (18-60years old) with ASA class I or II who will be scheduled for hand surgery. They will be equally divided into two groups: Group A (n =50) WALANT with hyaluronidase technique: Patients will receive a mixture of hyaluronidase 15 IU to every 1 ml lidocaine 1% mixture. Group B (n =50) WALANT without hyaluronidase technique: Patients will receive a mixture of lidocaine 1%. The infiltrative local anesthesia will be administered at the appropriate site in subcutaneous tissue just deep to the incisional site to produce tumescent local anesthesia. The onset time and duration of postoperative analgesia will be recorded.
Interventions
DRUGHyaluronidase and Lidocaine 1% mixture
in group A hyaluronidase is expected to shorten the onset of action and prolong the duration of action of lidocaine 1% mixture than in group B where lidocaine 1% mixture only will be given
DRUGlidocaine 1 % mixture
lidocaine 1 % mixture includes; A mixture of ( epinephrine 1:200,000 and lidocaine 1% ) buffered by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.
Sponsors
Misr University for Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All the above selected are blind regarding the used technique of anesthesia
Intervention model description
Two groups of participants will receive WALANT technique; 1. Group A (n=50); WALANT with Hyaluronidase 2. Group B (n=50); WALANT without Hyaluronidase
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* One hundred individuals scheduled for hand surgery * between the ages of 18 and 60 years old, * of both sexes * American Society of Anesthesiologists (ASA) classification I or II. * were randomized 1:1 to either Group A; (Receiving WALANT with hyaluronidase) or Group B; (Receiving WALANT without hyaluronidase).
Exclusion criteria
* Pregnant women, * patients who refused the terms of the research consent statement, * psychiatric illness, * uncooperative patient, * patients with history of allergy to local anesthetic drugs, * cardiac arrhythmia, * patients with bleeding tendency, * patients with low flow finger perfusion state such as Burger disease and Raynaud's disease, * patients with connective tissue disease such as Scleroderma * suspicious disease with malignancy and hand infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset time of analgesia. | from time of drug injection to start time of analgesia | time to start analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative analgesia | from onset time of analgesia to end of analgesia time postoperatively | duration of analgesia |
| Pain intensity | from start of pain postoperatively till the end of first 24 hours postoperatively | Pain intensity measured by Numerical Rating Scale (NRS) |
| The amount of morphine used | From start of postoperative pain to end of first 24 hours postoperatively | Dose of morphine used for analgesia postoperatively |
| Amount of bleeding | From start of surgery to end of sugery | Volume of blood loss |
| Patient satisfaction | From start of anesthesia till the end of first 24 hours postoperatively | Patient comfort with the technique |
Countries
Egypt
Outcome results
None listed