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

NCT07000058 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2022/0103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Hand Surgery; Local Infiltration

Keywords

WALANT; Wide-Awake; Hand surgery; Hyaluronidase

Outcome Measures

Primary Outcomes (1)

• Onset time of analgesia.

  time to start analgesia

  from time of drug injection to start time of analgesia

Secondary Outcomes (5)

• Duration of postoperative analgesia

  from onset time of analgesia to end of analgesia time postoperatively

• Pain intensity

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

• The amount of morphine used

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

• Amount of bleeding

  From start of surgery to end of sugery

• Patient satisfaction

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

Study Arms (2)

Group A (n=50): WALANT with Hyaluronidase

EXPERIMENTAL

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.

Drug: Hyaluronidase and Lidocaine 1% mixture

Group B (n=50): WALANT without Hyaluronidase:

ACTIVE COMPARATOR

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.

Drug: lidocaine 1 % mixture

Interventions

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

Also known as: Hyalase

Group A (n=50): WALANT with Hyaluronidase

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.

Also known as: Xylocaine 1%

Group B (n=50): WALANT without Hyaluronidase:

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr University for Science and Technology

Giza, Giza Governorate, 15525, Egypt

Location

Related Publications (3)

• 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.

  PMID: 33778124 BACKGROUND

• 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.

  PMID: 32258835 BACKGROUND

• 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.

  PMID: 36836799 BACKGROUND

MeSH Terms

Interventions

Hyaluronoglucosaminidase; Lidocaine

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohammed Hani Kamal, Prof.

  Anesth.&pain

  STUDY CHAIR

• Mohammed Safwat Hamza, Ass. prof.

  Orthopedics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All the above selected are blind regarding the used technique of anesthesia
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia& pain

Model Details: Two groups of participants will receive WALANT technique; 1. Group A (n=50); WALANT with Hyaluronidase 2. Group B (n=50); WALANT without Hyaluronidase

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: June 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After 5 months from today and wil be available for one year
• Access Criteria: Researchers: Who: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures. How: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals. Regulatory Authorities: Who: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications. Data Sharing Initiatives: Who: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases. Public and Patient Advocacy Groups: Who: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.

Locations

EG (1)