Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure.

Consorci Sanitari de Terrassa

Status: Active, not recruiting

Conditions: Distal Radius Fracture

Treatments: Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE

Study type: Interventional

Funder types: Other

Identifiers

NCT07318194

01-23-105-045

Details and patient eligibility

About

Analyse surgical field bleeding, surgical time, and intraoperative pain in patients undergoing osteosynthesis of distal radius fractures using ischaemia pressure calculated based on Limb Occlusion Pressure, compared with Arterial Occlusion Pressure. Additionally, compare muscle damage and postoperative complications, and clinical, functional, quality of life and radiological outcomes at one-year follow-up.

Full description

Randomised controlled clinical trial. It will be conducted with patients undergoing osteosynthesis of distal radius fractures (ischaemia pressure calculated according to Arterial Occlusion Pressure or Limb Occlusion Pressure), included consecutively at Terrassa Hospital from June 2023 to October 2025. The estimated sample size will be 70 patients per group. Pneumatic cuff pressure, ischaemia time, intraoperative ischaemia-related pain, surgical field bleeding, muscle damage, and postoperative complications will be assessed. One-year follow-up will include clinical, functional, quality-of-life, and radiological evaluations.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older, diagnosed with a distal radius fracture meeting surgical criteria.
• Surgery performed by the Hand Unit at Terrassa University Hospital.
• Axillary block as the anaesthetic technique.
• The surgeon completes all required study procedures.
• Written informed consent obtained from the patient.

Exclusion criteria

• Bilateral distal radius fractures.
• Osteosynthesis of an ipsilateral distal ulnar fracture.
• Requirement for general anaesthesia.
• High anaesthetic risk (ASA IV).
• Body mass index (BMI) > 40.
• Uncontrolled hypertension or treatment with more than three antihypertensive medications.
• Contraindications to tourniquet use, such as arteriovenous fistulas or peripheral vascular disease.
• Failure of the surgeon to complete the required study procedures.
• Lack of informed consent for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE

Experimental group

Description:

A distal sensor connected to the pneumatic tourniquet system is placed on the patient's index finger and automatically calculates the minimum ischaemia pressure required to occlude the distal blood flow.

Treatment:

Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE

PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE

Active Comparator group

Description:

Pneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure.

Treatment:

Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE