Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The duration of analgesia
研究概览
简要总结
Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine surgeries should be implemented to prevent CNS plasticity and to provide effective pain relief.
The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief.
The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine, dexmedetomidine), or their combination. This study will compare adding different non opioid adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine surgery which can be a part of multimodal analgesia protocol.
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详细描述
60 patient will be enrolled in the study. They will be allocated randomly into 3 groups. after induction of general anesthesia and changing the patient into prone position injection of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of the same mixture at the end of surgery) in all patients.
In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the second group we will add 50µg dexmedetomidine to the previous mixture given to the first group.
In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group
During the operation adjustment of sevoflurane concentration and fentanyl incremental doses (0.5 μg/kg) will be according to hemodynamic measurements.
Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the study.
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
- Quadruple (Participant, Care Provider, Investigator, 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 are aged from 18-65 years , ASA I and II, scheduled for lumbar spine surgery (laminectomy, discectomy, foraminotomy, fenestration or fusion) in a virgin back.
排除标准
- •Patients with multiple level fixation, revision surgery, complicated spinal canal stenosis, traumatic lumbar surgeries were excluded, patients with addiction, allergy to local anesthetics or to any drug used in the study and those with coagulation abnormality are also excluded from the study.
研究组 & 干预措施
group A
patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery
干预措施: Dexamethasone (Drug)
group A
patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery
干预措施: Bupivacaine (Drug)
group B
we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery
干预措施: Bupivacaine (Drug)
group B
we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery
干预措施: Dexamethasone (Drug)
group B
we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery
干预措施: Dexmedetomidine (Drug)
group c
we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery
干预措施: Bupivacaine (Drug)
group c
we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery
干预措施: Dexamethasone (Drug)
group c
we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery
干预措施: Hyalouridinase (Drug)
结局指标
主要结局
The duration of analgesia
时间窗: postoerative 24 hours.
time from second dose caudal epidural block to first analgesic requirement
次要结局
- postoperative pain(postoperative 24 hours)
研究者
Sanaa Farag Mahmoud Wasfy
principal investigator
Ain Shams University