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

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05832021
Collaborator
(none)
48
1
13
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Open reduction and internal fixation (under WALANT)
  • Procedure: Open reduction and internal fixation (under peripheral nerve block)

Study Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Apr 19, 2021
Actual Primary Completion Date :
May 20, 2022
Actual Study Completion Date :
May 20, 2022

Arms and Interventions

Arm Intervention/Treatment
WALANT

Patients with distal radius fracture who underwent surgical treatment under WALANT.

Procedure: Open reduction and internal fixation (under WALANT)
Open reduction and internal fixation with volar Henry approach under WALANT.

Peripheral nerve block

Patients with distal radius fracture who underwent surgical treatment under peripheral nerve block.

Procedure: Open reduction and internal fixation (under peripheral nerve block)
Open reduction and internal fixation with volar Henry approach under peripheral nerve block.

Outcome Measures

Primary Outcome Measures

  1. Changes in the patient's pain [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 [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 Outcome Measures

  1. Number of complications after surgery [Collected at end of follow up (24 months)]

    Description of complications regarding surgery or anesthetical technique

  2. Evolution in postoperative wrist mobility [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Yildirim Beyazit Education and Research Hospital Ankara Turkey 06110

Sponsors and Collaborators

  • Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huseyin Bilgehan Cevik, MD, Assoc Prof, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05832021
Other Study ID Numbers:
  • 109/21
First Posted:
Apr 27, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huseyin Bilgehan Cevik, MD, Assoc Prof, Diskapi Yildirim Beyazit Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023