Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
研究概览
简要总结
This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant age≥ 65 years
- •Body mass index (BMI) < 30kg/m2
- •American Society of Anesthesiologists (ASA) classification I-II
- •Anterior operative incision approach
排除标准
- •Request for general anesthesia
- •Nerve block is unable to be performed due to various reasons
- •Coagulation dysfunction or anticoagulation therapy
- •History of upper limb nerve injury or phrenic nerve injury
- •Multiple trauma
- •Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
- •Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
- •Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
- •Stroke or cognitive dysfunction (unable to communicate or cooperate)
- •Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
研究组 & 干预措施
IC group
Interscalene brachial plexus-Cervical plexus
干预措施: interscalene brachial plexus block and superficial cervical plexus block (Procedure)
ICTP group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
干预措施: T2 paravertebral block (Procedure)
ICTP group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
干预措施: interscalene brachial plexus block and superficial cervical plexus block (Procedure)
结局指标
主要结局
Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
时间窗: throughout the operation duration, an average of 2 to 3 hours
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
次要结局
- Assessment of Sensory Blockade(20 minutes after all the nerve block operations have been finished)
- Proportion of Participants Completed the Procedure With Remifentanil(throughout the operation duration, an average of 2 to 3 hours)
- Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)(throughout the operation duration, an average of 2 to 3 hours)
- Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)(At the end of surgical procedure(an average of 2 to 3 hours))
- Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)(At the end of surgical procedure(an average of 2 to 3 hours))
- Complications Related With Anesthesia(within 24 hours since the nerve block finished)
- Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)(throughout the operation duration, an average of 2 to 3 hours)
研究者
Xiaofeng WANG
Principal Investigator
Shanghai 6th People's Hospital