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NCT Number: NCT07000058

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

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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Key information

Conditions

Hand Surgery Local Infiltration

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Misr University for Science and Technology

Giza, Giza Governorate, 15525, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronidase and Lidocaine 1% mixture

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

Other names: Hyalase

lidocaine 1 % mixture

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.

Other names: Xylocaine 1%

Primary outcomes

  1. Onset time of analgesia.

    Time frame: from time of drug injection to start time of analgesia

    time to start analgesia

Secondary outcomes

  1. Duration of postoperative analgesia

    Time frame: from onset time of analgesia to end of analgesia time postoperatively

    duration of analgesia

  2. Pain intensity

    Time frame: from start of pain postoperatively till the end of first 24 hours postoperatively

    Pain intensity measured by Numerical Rating Scale (NRS)

  3. The amount of morphine used

    Time frame: From start of postoperative pain to end of first 24 hours postoperatively

    Dose of morphine used for analgesia postoperatively

  4. Amount of bleeding

    Time frame: From start of surgery to end of sugery

    Volume of blood loss

  5. Patient satisfaction

    Time frame: From start of anesthesia till the end of first 24 hours postoperatively

    Patient comfort with the technique

Sponsors and collaborators

Lead sponsor

Misr University for Science and Technology

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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