Analgesic Efficacy of the Infraspinatus-Teres Minor (ITM) Interfascial Plane Block After Shoulder Arthroscopy: A Simon's Two-Stage Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Analgesic efficacy
研究概览
简要总结
The main study objective is to observe the ability of the ITM block to provide clinically acceptable pain control after elective shoulder arthroscopy as measured by pain scores and morphine consumption.
The secondary objectives are determining its trajectory of efficacy up to 24 hours by measure of pain scores, morphine consumption and side effects.
详细描述
Significant post-operative pain follows shoulder arthroscopy. Currently the interscalene brachial plexus (ISB) block is recommended as the first-choice regional anaesthesia technique (1). However, interscalene bloc is associated with phrenic nerve paralysis for the duration of the block which can exacerbate pulmonary co-morbidities, as well as motor block of the arm which can decrease patient autonomy. An alternative to the interscalene block is the combined suprascapular nerve and axillary nerve (SSAX) block (2). However, this requires two needle punctures and is more difficult to perform technically. Recently, the Infraspinatus Teres Minor Interfascial Plane (ITM) block was developed by Kim et al (1) to anaesthetise the suprascapular and axillary nerves with a single approach. As a fascial plane block, its high safety profile and ease of performance make it a potentially safer alternative the SSAX block when the ISB is contraindicated.
A monocentric, prospective Simon two-stage trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study population inclusion criteria will be:
- •Patients of any sex
- •Class ASAI-III
- •Patients 18 years of age or older
- •Scheduled for elective shoulder arthroscopy
- •Able to give written informed consent autonomously
- •Sex and gender dimensions are irrelevant for this study as enrolled patients are benefitting from shoulder surgery without reference to gender and our standard care as well as our research disposition is indiscriminately applied to all genders.
排除标准
- •The subject exclusion criteria will be:
- •Allergy to any of: ropivacaine, paracetamol, celecoxib, morphine, ondansetron or dexamethasone
- •Refusal or inability to give consent
- •Bleeding diathesis (according to HEMSTOP score)
- •Neurological deficit of the operative side
- •Existing preoperative chronic opioid use (greater than or equal to 3 months of use)
- •Renal insufficiency (GFR<30ml/min according to the Cockroft-Gault formula)
- •Known or suspected non-compliance
- •Illicit drug use
- •Excessive alcohol use (<8 drinks per week for women, >15 drinks per week for men)
- •Inability to follow the procedures of the study, e.g due to language problems, psychiatric disorder, dementia, etc
- •Participation in another study with an investigational medicinal product within 30 days preceding the study and during the study
- •Hepatic insufficiency (CHILD-Pugh score B or C)
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Intervention
Single arm interventional group in a Simon's two stage design
干预措施: Infraspinatus-teres minor block (Other)
结局指标
主要结局
Analgesic efficacy
时间窗: 24 hours
The binary primary endpoint is block success, requiring the two following criteria: 1. Early treatment success: defined as the absence of treatment failure during the initial 2 postoperative hours, which is either; the requirement for greater thann or equal to10mg of intravenous morphine with a VAS pain score \>3, or a VAS pain score of greater than or equal to 7 at any time during this period. 2. Twenty-four-hour analgesic success: defined as a VAS pain score \<4 at 24 hours postoperatively while consuming no more than 30mg oral morphine reserves.
Analgesic efficacy
时间窗: At 2 hours postoperatively and at 24 hours postoperatively.
The binary primary endpoint is block success, requiring the two following criteria: 1. Early treatment success: defined as the absence of treatment failure during the initial 2 hours postoperatively. Treatment failure is defined as either the requirement for greater than or equal to 10 mg of intravenous morphine and a VAS pain score \>3, or a VAS pain score of greater than or equal to 7 at any time during this period. 2. Twenty-four-hour analgesic success: defined as a VAS pain score \<4 at 24 hours postoperatively while consuming no more than 30 mg of reserve oral morphine.
次要结局
未报告次要终点
研究者
Eric Albrecht
Professor Dr. Med Eric Albrecht
Centre Hospitalier Universitaire Vaudois