NCT07000058

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Misr University for Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hand Surgery
• Local Infiltration

Interventions

Type	Name	Description
DRUG	Hyaluronidase 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
DRUG	lidocaine 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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-05-31
• Last updated: 2025-07-29

Locations

1 site across 1 country: Egypt