Wide-Awake Local Anesthesia No Tourniquet (WALANT) With Versus Without Hyaluronidase for Hand Surgery

Phase 2

Recruiting

• Conditions: Hand Surgery
• Interventions: Drug: Hyaluronidase and Lidocaine 1% mixture; Drug: lidocaine 1 % mixture

• Registration Number: NCT07000058
• Lead Sponsor: Misr University for Science and Technology

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study Start: 2025-05-25
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• One hundred individuals scheduled for hand surgery between the ages of 18 and 60 years old, of both sexes and 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 and suspicious disease with malignancy and hand infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (n=50): WALANT with Hyaluronidase	Hyaluronidase and Lidocaine 1% mixture	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.
Group B (n=50): WALANT without Hyaluronidase:	lidocaine 1 % mixture	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.

Primary Outcome Measures

Name	Time	Method
Onset time of analgesia.	from time of drug injection to start time of analgesia	time to start analgesia

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Misr University for Science and Technology ( MUST); 🇪🇬 Giza, Egypt