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Completed

NCT Number: NCT05832021

Comparison of Clinical Outcomes of Distal Radius Fractures Treated Surgically With WALANT and Peripheral Nerve Block

WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high patient satisfaction. There are studies with a high level of evidence showing that the WALANT technique has such advantages in soft tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.), surgical treatment is performed with the WALANT technique and positive results have been reported. Although there is a study comparing WALANT and general anesthesia in the surgical treatment of distal radius fractures, there is no study comparing the peripheral nerve block technique.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diskapi Yildirim Beyazit Education and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years of age
  • Patients who had acute distal radius fracture which underwent surgery

Exclusion criteria

  • Patients with open fractures
  • Additional injuries in the same extremity, peripheral vascular disease, and local anesthetic allergy at the time of first admission
  • Patients who are switched to general anesthesia after both techniques
  • Patients who underwent a second surgery on the same extremity due to any complication
  • Patients who had lacked follow-up examination information

Treatment and study plan

Open reduction and internal fixation (under WALANT)

Procedure

Open reduction and internal fixation with volar Henry approach under WALANT.

Open reduction and internal fixation (under peripheral nerve block)

Procedure

Open reduction and internal fixation with volar Henry approach under peripheral nerve block.

Primary outcomes

  1. Changes in the patient's pain

    Time frame: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

    Visual Analogue Scale (VAS) scale (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) to measure pain level

  2. Changes in the patient's anxiety

    Time frame: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

    State-Trait Anxiety Inventory (STAI-TX) (no anxiety: 1 point, a little anxiety: 2 points, anxious: 3 points, very anxious: 4 points) to measure anxiety

Secondary outcomes

  1. Number of complications after surgery

    Time frame: Collected at end of follow up (24 months)

    Description of complications regarding surgery or anesthetical technique

  2. Evolution in postoperative wrist mobility

    Time frame: Baseline, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

    Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (degree)

  3. Number of patients who need conversion to general anaesthesia due to lack of effectiveness of anaesthetic technique

    Time frame: During surgery (intraoperative)

    Yes or no answer to the question "did the patient need reconversion to general anaesthesia?"

  4. Description of reason why the patient needed adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique

    Time frame: During surgery (intraoperative)

    Open ended question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)

  5. Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia

    Time frame: During surgery (intraoperative)

    Open ended question describing the technique used in order to resolve lack of anaesthesia if needed (sedation, extra doses of local anaesthetic, anatomic location of local anaesthetic, doses of local anaesthetic, etc)

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Patients With Distal Radius Fracture Who Underwent Surgery With WALANT Technique or Peripheral Nerve Block Anesthesia Methods in Terms of Patient Satisfaction and Functional Results in the Postoperative Period

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2023
Registry last updated
May 1, 2023

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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