Skip to main content
Clinical Trials/NCT05832021
NCT05832021
Completed
Not Applicable

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

Diskapi Yildirim Beyazit Education and Research Hospital1 site in 1 country48 target enrollmentApril 19, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Enrollment
48
Locations
1
Primary Endpoint
Changes in the patient's anxiety
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 19, 2021
End Date
May 20, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Huseyin Bilgehan Cevik

MD, Assoc Prof

Diskapi Yildirim Beyazit Education and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Number of complications after surgery(Collected at end of follow up (24 months))
  • 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))
  • Evolution in postoperative wrist mobility(Baseline, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery)
  • Number of patients who need conversion to general anaesthesia due to lack of effectiveness of anaesthetic technique(During surgery (intraoperative))
  • Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia(During surgery (intraoperative))

Study Sites (1)

Loading locations...

Similar Trials