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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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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

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Hand Surgery Local Infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

All the above selected are blind regarding the used technique of anesthesia

Study Groups

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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.

Group Type EXPERIMENTAL

Hyaluronidase and Lidocaine 1% mixture

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

lidocaine 1 % mixture

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hyalase Xylocaine 1%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes