Clinical trial NCT07000058: Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
Official title: Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hand Surgery
Local Infiltration
Keywords: WALANT
Wide-Awake
Hand surgery
Hyaluronidase
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Onset time of analgesia.
timeFrame: from time of drug injection to start time of analgesia
Secondary outcomes:
measure: Duration of postoperative analgesia
timeFrame: from onset time of analgesia to end of analgesia time postoperatively
measure: Pain intensity
timeFrame: from start of pain postoperatively till the end of first 24 hours postoperatively
measure: The amount of morphine used
timeFrame: From start of postoperative pain to end of first 24 hours postoperatively
measure: Amount of bleeding
timeFrame: From start of surgery to end of sugery
measure: Patient satisfaction
timeFrame: From start of anesthesia till the end of first 24 hours postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
affiliation: Anesth.&pain
name: Mohammed Hani Kamal, Prof.
role: STUDY_CHAIR
affiliation: Orthopedics
name: Mohammed Safwat Hamza, Ass. prof.
role: STUDY_DIRECTOR
References:
citation: Farzam R, Deilami M, Jalili S, Kamali K. Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial. Arch Bone Jt Surg. 2021 Jan;9(1):116-121. doi: 10.22038/abjs.2020.49526.2487.
citation: O'Neill N, Abdall-Razak A, Norton E, Kumar A, Shah H, Khatkar H, Alsafi Z, Agha R. Use of Wide-Awake Local Anaesthetic No Tourniquet (WALANT) in upper limb and hand surgery: A systematic review protocol. Int J Surg Protoc. 2020 Mar 13;20:8-12. doi: 10.1016/j.isjp.2020.03.001. eCollection 2020.
citation: Seretis K, Boptsi A, Boptsi E, Lykoudis EG. The Efficacy of Wide-Awake Local Anesthesia No Tourniquet (WALANT) in Common Plastic Surgery Operations Performed on the Upper Limbs: A Case-Control Study. Life (Basel). 2023 Feb 4;13(2):442. doi: 10.3390/life13020442.