Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the total number of analgesic requests
研究概览
简要总结
the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
- •ASA physical status I - Ш.
排除标准
- •Infection at the site of injection.
- •Coagulopathy or other bleeding diathesis.
- •Known allergy to drugs in the study
- •Preexisting neurologic deficits in the area to be blocked.
- •Inability to communicate with the investigator and the hospital staff.
- •History of chronic opioid use.
- •Morbid obesity BMI>40.
研究组 & 干预措施
Morphine
5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
干预措施: Morphine (Drug)
Nalbuphine
5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
干预措施: Nalbuphine (Drug)
Morphine and Nalbuphine
5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
干预措施: Morphine (Drug)
Morphine and Nalbuphine
5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
干预措施: Nalbuphine (Drug)
Bupivacaine 0.5%
10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
干预措施: Bupivacaine 0.5% (Drug)
结局指标
主要结局
the total number of analgesic requests
时间窗: 72 hours postoperative followup
the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.
次要结局
- patient satisfaction(72 hours followup)
- The first time to ask for analgesics(72 hours followup)
- duration of analgesia(72 hours followup)
- sedation score(72 hours followup)
- number of vomiting attacks(72 hours followup)
- itching(72 hours followup)
研究者
Shimaa Abbas Hassan
Primary investigator
Assiut University