Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Onset time of analgesia.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All the above selected are blind regarding the used technique of anesthesia
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: lidocaine 1 % mixture (Drug)
结局指标
主要结局
Onset time of analgesia.
时间窗: from time of drug injection to start time of analgesia
time to start analgesia
次要结局
- 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)
研究者
Emad Lotfy Mohammed Ahmed
Lecturer of anesthesia& pain
Misr University for Science and Technology