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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2026-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE

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.

Group Type EXPERIMENTAL

PNEUMATIC TOURNIQUET INFLATION PRESSURE

Intervention Type PROCEDURE

Patients undergoing osteosynthesis of distal radius fractures will be randomised in two groups: pneumatic cuff pressure calculated based on Limb Occlusion Pressure, and pneumatic cuff pressure calculated based on Arterial Occlusion Pressure, without adding any security margin in any group.

PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE

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

Group Type ACTIVE_COMPARATOR

PNEUMATIC TOURNIQUET INFLATION PRESSURE

Intervention Type PROCEDURE

Patients undergoing osteosynthesis of distal radius fractures will be randomised in two groups: pneumatic cuff pressure calculated based on Limb Occlusion Pressure, and pneumatic cuff pressure calculated based on Arterial Occlusion Pressure, without adding any security margin in any group.

Interventions

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PNEUMATIC TOURNIQUET INFLATION PRESSURE

Patients undergoing osteosynthesis of distal radius fractures will be randomised in two groups: pneumatic cuff pressure calculated based on Limb Occlusion Pressure, and pneumatic cuff pressure calculated based on Arterial Occlusion Pressure, without adding any security margin in any group.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No