Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Onset time of analgesia.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
All the above selected are blind regarding the used technique of anesthesia
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group A (n=50): WALANT with Hyaluronidase
Patients received a mixture of hyaluronidase 15 IU to every 1 ml lidocaine 1% mixture (a solution composed of epinephrine 1:200,000 and lidocaine 1%). Buffered to reduce injection pain by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.
Intervention: Hyaluronidase and Lidocaine 1% mixture (Drug)
Group B (n=50): WALANT without Hyaluronidase:
A mixture of epinephrine 1:200,000 and lidocaine 1% buffered to reduce injection pain by 1 ml of sodium bicarbonate 8.4% for every 10 ml of the local anesthetic mixture.
Intervention: lidocaine 1 % mixture (Drug)
Outcomes
Primary Outcomes
Onset time of analgesia.
Time Frame: from time of drug injection to start time of analgesia
time to start analgesia
Secondary Outcomes
- Duration of postoperative analgesia(from onset time of analgesia to end of analgesia time postoperatively)
- Pain intensity(from start of pain postoperatively till the end of first 24 hours postoperatively)
- The amount of morphine used(From start of postoperative pain to end of first 24 hours postoperatively)
- Amount of bleeding(From start of surgery to end of sugery)
- Patient satisfaction(From start of anesthesia till the end of first 24 hours postoperatively)
Investigators
Emad Lotfy Mohammed Ahmed
Lecturer of anesthesia& pain
Misr University for Science and Technology