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Hand SurgeryPhase 2/3NCT07000058

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

A Phase 2/3 study testing Hyaluronidase and Lidocaine 1% mixture and lidocaine 1 % mixture in people with Hand Surgery and Local Infiltration, run by Misr University for Science and Technology at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hand Surgery, Local Infiltration
What is being tested?
Hyaluronidase and Lidocaine 1% mixture and lidocaine 1 % mixture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
20 Jun 2025to 31 Dec 2025
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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,
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Misr University for Science and Technology

    Giza, Giza Governorate, 15525

Other trials in Egypt

About this study

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).

Read the 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.

Being tested
Hyaluronidase and Lidocaine 1% mixture, lidocaine 1 % mixture
Keywords
WALANT, Wide-Awake, Hand surgery, Hyaluronidase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronidase and Lidocaine 1% mixtureDrug

    Also called Hyalase

    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

  • lidocaine 1 % mixtureDrug

    Also called Xylocaine 1%

    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.

Study groups in NCT07000058
Study groupRoleWhat they receive
Group A (n=50): WALANT with HyaluronidaseExperimentalPatients 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.
Receives: Drug: Hyaluronidase and Lidocaine 1% mixture
Group B (n=50): WALANT without Hyaluronidase:Active comparatorA 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.
Receives: Drug: lidocaine 1 % mixture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Onset time of analgesia.

    time to start analgesia

    Measured: from time of drug injection to start time of analgesia

Secondary outcomes (5)

  1. Duration of postoperative analgesia

    duration of analgesia

    Measured: from onset time of analgesia to end of analgesia time postoperatively

  2. Pain intensity

    Pain intensity measured by Numerical Rating Scale (NRS)

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

  3. The amount of morphine used

    Dose of morphine used for analgesia postoperatively

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

  4. Amount of bleeding

    Volume of blood loss

    Measured: From start of surgery to end of sugery

  5. Patient satisfaction

    Patient comfort with the technique

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start20 Jun 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07000058
Sponsor's protocol ID
2022/0103
Status last verified
Jul 2025
First submitted
23 May 2025
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Demographic Information: Age, sex, race, and other relevant demographic details. Baseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial. Treatment Assignment: Information on the intervention or treatment each participant received. Outcome Measures: Data on primary and secondary outcomes as defined in the trial protocol. Adverse Events: Reports of any side effects or adverse events experienced by participants during the trial. Follow-up Data: Information collected during follow-up periods, including long-term outcomes.

Publications

  • 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.

    PubMed 33778124

  • 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.

    PubMed 32258835

  • 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.

    PubMed 36836799

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hyaluronidase and Lidocaine 1% mixture and lidocaine 1 % mixture in people with Hand Surgery and Local Infiltration, run by Misr University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset time of analgesia. (time frame: from time of drug injection to start time of analgesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07000058, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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