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

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Open reduction and internal fixation (under WALANT); Procedure: Open reduction and internal fixation (under peripheral nerve block)

• Registration Number: NCT05832021
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-19
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Study First Submitted: 2022-11-15
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-27
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WALANT	Open reduction and internal fixation (under WALANT)	Patients with distal radius fracture who underwent surgical treatment under WALANT.
Peripheral nerve block	Open reduction and internal fixation (under peripheral nerve block)	Patients with distal radius fracture who underwent surgical treatment under peripheral nerve block.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Number of complications after surgery	Collected at end of follow up (24 months)	Description of complications regarding surgery or anesthetical technique
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)
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)
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?"
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)

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Education and Research Hospital; 🇹🇷 Ankara, Turkey