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Clinical Trials in Spain / NCT07318194
Active, not recruiting Not applicable

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

NCT07318194 · tracked via the Priya Life Science Spain tracker
Sponsor
Consorci Sanitari de Terrassa
Phase
Not applicable
Started
2023-06-06
Last updated
2026-01-05

Condition(s) studied

Distal Radius Fracture

Investigational drug(s) / intervention(s)

PNEUMATIC TOURNIQUET INFLATION PRESSURE

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • SURGICAL FIELD BLEEDING — At the end of the surgery.
    Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)
  • ISCHAEMIA TIME — Measured at the end of the surgery.
    Measured in minutes. It refers to the duration from the onset of pneumatic ischemia until its cessation, prior to wound closure at the end of the surgery.
  • INTRAOPERATORY PAIN — Measured 60 minutes after the start of the surgery.
    Pain caused by the pneumatic cuff on the arm, measured using the Visual Analogue Scale (0-10). 0 (the best) - 10 (the worst)
  • COMPLICATIONS — During the surgery or the immediate postoperative period.
    Any cutaneous, muscular, vascular or nervous complication.
  • MUSCLE DAMAGE — In postoperative blood tests 60 minutes after surgery.
    Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.
  • LIMB OCCLUSION PRESSURE — Measured inside the operating room immediately prior to the start of surgery.
    Measured in mmHg. Automatically recorded by placing a distal sensor on the index finger (second digit) of the hand, connected to the pneumatic ischemia device. No safety margin will be applied. A single measurement will be taken.
  • ARTERIAL OCCLUSION PRESSURE — Measured inside the operating room immediately prior to the start of surgery.
    Expressed in mmHg. Calculated using the formula: systolic blood pressure + 100 mmHg.

Trial sites (1)

FacilityCityRegionStatus
JM Mora, Terrassa, Barcelona, 08227 Terrassa Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07318194 on ClinicalTrials.gov ↗ ← All trials in Spain