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

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Open reduction and internal fixation (under WALANT); Procedure: Open reduction and internal fixation (under peripheral nerve block)

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Diskapi Yildirim Beyazit Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A total of 50 patients are planned to be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the patient's pain	Visual Analogue Scale (VAS) scale (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) to measure pain level	Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Changes in the patient's anxiety	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	Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications after surgery	Description of complications regarding surgery or anesthetical technique	Collected at end of follow up (24 months)
Evolution in postoperative wrist mobility	Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (degree)	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	Yes or no answer to the question "did the patient need reconversion to general anaesthesia?"	During surgery (intraoperative)
Description of reason why the patient needed adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique	Open ended question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)	During surgery (intraoperative)
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia	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)	During surgery (intraoperative)

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Distal Radius Fracture; Peripheral nerve block; WALANT
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 109/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No