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

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832021
• Other study ID #: 109/21
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: April 2023
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of complications after surgery	Description of complications regarding surgery or anesthetical technique	Collected at end of follow up (24 months)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)