Comparative Study Between Erector Spinae Plane Block Versus Intravenous Morphine as Postoperative Analgesia After Spine Surgeries .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative analgesia .
研究概览
简要总结
Postoperative pain is often severe in patients undergoing lumbar surgery. Due to postoperative pain, patients are unwilling to get out of bed at an early stage, which affects their recovery.
Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial.
The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process .
The technique is performed under ultrasound guidance.
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
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar Disc Prolapse.
- •Fracture Lumbar Vertebrae
排除标准
- •Patient refusal.
- •Drug abuse.
- •Patient with significant neurological, psychiatric or neuromuscular disease.
- •Chronic pain on medicine.
- •known allergy to the study medications.
- •Infection at the site of infiltration.
- •Patients with bleeding tendency.
研究组 & 干预措施
Erector Spinae Plane block group
(30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ).
干预措施: Erector Spinae plane block (plain pubivicaine) (Drug)
Intravenous Morphine group
(30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.
干预措施: Intravenous morphine group (Drug)
结局指标
主要结局
Postoperative analgesia .
时间窗: 24 hours after surgery
The study will include 60 adult patients undergoing uncomplicated spine surgery under general anesthesia. At the end of operation , Patients will be randomly divided using closed enveloped method into two equal groups. * Group 1, (30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ). * Group 2, (30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation. postoperative pain assessment according to visual analogue scale ( VAS ) within 24 hours after the surgery. 0 - 3 mild pain ( better outcome ) 4 - 6 moderate pain 7 - 10 severe pain \> 10 unbearable pain ( worst outcome)
次要结局
- Avoid side effects of using systemic morphine.(24 hours after surgery)
研究者
Mohamed Aboelhamed Abdelrahman
resident doctor at Anasthesia department sohag university hospital
Sohag University