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

NCT05832021 | Completed

• 1 other identifier: 109/21
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Keywords

WALANT; Distal Radius Fracture; Peripheral nerve block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of complications after surgery

  Collected at end of follow up (24 months)

• 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)

• 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)

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

  During surgery (intraoperative)

Study Arms (2)

WALANT

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

Procedure: Open reduction and internal fixation (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)

Interventions

Open reduction and internal fixation (under WALANT) PROCEDURE

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

WALANT

Open reduction and internal fixation (under peripheral nerve block) PROCEDURE

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

Peripheral nerve block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazit Education and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assoc Prof

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: April 27, 2023
• Study Start: April 19, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)