Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Total post-operative morphine consumption.
研究概览
简要总结
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.
详细描述
the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 20 years old.
- •ASA II to III patients undergoing elective cardiac surgery via a median sternotomy
排除标准
- •Patient's refusal.
- •Known contraindications to regional blocks, including local skin infections,and coagulopathy.
- •Allergies to the local anaesthetics used.
- •Patients undergoing complex cardiac procedures.
- •Patients with severe chronic obstructive pulmonary disease.
- •Patients unable to communicate.
- •Patients with chronic pain.
- •Patients with severe pulmonary hypertension.
研究组 & 干预措施
Levobupivacaine group
- Patients in this group shall receive levobupivacaine alone.
- Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
干预措施: transversus thoracis plane block (Procedure)
Levobupivacaine group
- Patients in this group shall receive levobupivacaine alone.
- Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
干预措施: Levobupivacaine (Drug)
Combined levobupivacaine, and dexmeditomedine group
- Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant.
- Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
干预措施: transversus thoracis plane block (Procedure)
Combined levobupivacaine, and dexmeditomedine group
- Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant.
- Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
干预措施: Dexmedetomidine (Drug)
Combined levobupivacaine, and dexmeditomedine group
- Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant.
- Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Total post-operative morphine consumption.
时间窗: 24 hours post-operative
If the patient experiences a pain of \> 4, he will be given morphine intravenously in a dose of 0.05 mg/kg IV by a blinded assessor, aiming for a pain score of ≤ 4. The total morphine dose for the post-operative 24 hours will be compared between the case and control group, to determine which technique provided more analgesia.
次要结局
- Post-operative pain score(24 hours post-operative)
- Complications of the interventional block(24 hours post-operative)
- Intensive Care Unit (ICU) stay length.(4 days)
- Time till request of first analgesia.(24 hours post-operative)
研究者
Ahmed wahby Shamsedine
Assistant Lecturer
Assiut University