Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure: Limb Occlusion Pressure Versus Arterial Occlusion Pressure. And Clinical, Radiological and Quality of Life Assessment at One-year Follow up. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- SURGICAL FIELD BLEEDING
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Bilateral distal radius fractures.
- •Osteosynthesis of an ipsilateral distal ulnar fracture.
- •Requirement for general anaesthesia.
- •High anaesthetic risk (ASA IV).
- •Body mass index (BMI) >
- •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.
研究组 & 干预措施
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.
干预措施: PNEUMATIC TOURNIQUET INFLATION PRESSURE (Procedure)
PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE
Pneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure.
干预措施: PNEUMATIC TOURNIQUET INFLATION PRESSURE (Procedure)
结局指标
主要结局
SURGICAL FIELD BLEEDING
时间窗: At the end of the surgery.
Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)
ISCHAEMIA TIME
时间窗: 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
时间窗: 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
时间窗: During the surgery or the immediate postoperative period.
Any cutaneous, muscular, vascular or nervous complication.
MUSCLE DAMAGE
时间窗: In postoperative blood tests 60 minutes after surgery.
Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.
LIMB OCCLUSION PRESSURE
时间窗: 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
时间窗: Measured inside the operating room immediately prior to the start of surgery.
Expressed in mmHg. Calculated using the formula: systolic blood pressure + 100 mmHg.
次要结局
- FRACTURE TYPE(Preoperative)
- SYSTOLIC BLOOD PRESSURE(Measured inside the operating room, after the patient has been lightly sedated.)
- PRWE TEST(Assessed one year postoperatively)
- GRIP STRENGTH(Assessed one year postoperatively.)
- QUICK-DASH TEST(Assessed one year postoperatively)
- RANGE OF MOVEMENT(Assessed one year postoperatively)
- SF-12 TEST(Assessed one year postoperatively.)
- BODY MASS INDEX(Preoperative)
- EUROQOL-5D TEST(Assessed one year postoperatively.)
- ARM CIRCUMFERENCE(Preoperative.)
研究者
Josep Maria Mora Guix
MD, PhD. Chief of Shoulder Unit
Consorci Sanitari de Terrassa