A Novel Approach to Shoulder Analgesia: Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- total amount of rescue analgesic consumption
研究概览
简要总结
The aim of the study to evaluate the efficacy of the infraspinatus-teres minor (ITM) block in improving pre-emptive analgesia, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing shoulder surgeries.
详细描述
To compare between infraspinatus-teres minor versus control group (GA):
- To measure analgesic parameters including: the total amount of rescue analgesic consumption (morphine) in the first 24 hours post-operatively in each group, duration of analgesia, and total amount of intraoperative fentanyl consumption and
- To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder joint (dynamic).
- To assess discharge time from post anesthesia care unit (PACU).
- To assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block.
- Patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).
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)
盲法说明
Anesthetist not sharing in the study will assess outcomes
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients' acceptance.
- •Age: Adults aged 21-65 years old.
- •BMI: 25-30 kg/m2
- •Sex: both sexes (males or females).
- •Patients undergoing unilateral shoulder surgey under general anesthesia.
- •ASA (American Society of Anesthesiologists) physical status classification I to II.
- •Duration of the surgery < 3hours.
排除标准
- •• Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant).
- •Allergy to study medications: bupivacaine or dexamethasone, or dexmedetomidine
- •Patients with severe cardiovascular, respiratory, renal, or hepatic diseases, uncontrolled diabetes , or those undergoing chronic opioid therapy.
- •Psychiatric disorders that hinder informed consent or study participation.
- •history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).
- •Patients with nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, or patients with abnormal sensory or motor function of the upper limb.
研究组 & 干预措施
*Group Infraspinatus teres minor block (ITM group)
Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia
干预措施: Infraspinatus teres minor block group (Procedure)
Control group (group C)
Patients in this group will receive general anesthesia.
干预措施: Control group (Procedure)
结局指标
主要结局
total amount of rescue analgesic consumption
时间窗: for 24 hours
To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group.
total amount of intraoperative supplementary fentanyl consumption.
时间窗: up to 3 hours
To measure total amount of intraoperative supplementary fentanyl consumption.
次要结局
- To assess side effects of systemic opioids(for 24 hours)
- Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic).(30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.)
- Time to the first request of rescue analgesia postoperatively(24 hours postoperative)
- Discharge time from post anesthesia care unit (PACU)(24 hours)
- the incidence of block -related side effects or complications(for 24 hours)
- patient's satisfaction(for 24 hours)
研究者
Dina Abdelhameed Elsadek Salem
principle investigator
Zagazig University