Effect of low dose intrathecal morphine as a part of multimodal analgesia in patients undergoing cardiac surgeries through sternotomy – open-label randomized control trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To assess postoperative pain by visual analogue scale (VAS) score
研究概览
简要总结
| Title |
Effect of low dose intrathecal morphine as a part of multimodal analgesia in patients undergoing cardiac surgeries through sternotomy - prospective randomized control trial
|Study center
All India Institute of Medical Sciences, Raipur, India
|Phase
Randomized Control Trial - Phase 3
|Methodology
Single-center, open-label randomized controlled trial
|Study duration
1.5 years
|Objectives
Primary:
To assess the quality of Analgesia based on VAS pain score in the postoperative period for 24 hours.
Secondary:
To assess the total opioid consumption with rescue analgesia and other associated complications.
|Number of subjects
104
|Main inclusion and exclusion criteria
Inclusion criteria:
· Patients of age 18 to 65 years undergoing midline sternotomy for cardiac surgeries.
· New York Heart Association grade II-III patients.
Exclusion criteria:
· Patient refusal. · Contraindication to intrathecal analgesia: infection at injection site, coagulopathy, allergy to morphine. · Pre-existing chronic pain: taking routine analgesics. · Patients with a history of chronic opiate abuse. · Patients with psychiatric disorders. · Patients with previous surgery in the thoracic vertebral region. · Preexisting neurological condition (spinal cord injury, multiple sclerosis, etc.). · Patients with BMI more than or equal to 35. · Patients with severe respiratory disease. · Those expected to be on elective mechanical ventilation for >6 hours postoperatively. · Patients with renal dysfunction (Serum creatinine > 1.5 mg/dl).
|Intervention
| P |
Population
Patients aged 18 to 65 years undergoing midline sternotomy for cardiac surgeries
|I
Intervention
Intrathecal morphine
|C
Control
Standard treatment
|O
Outcomes
Postoperative pain by visual analogue scale (VAS) score
|Outcomes
Primary outcome: To assess postoperative pain by visual analogue scale (VAS) score.Secondary outcome: 1. Total dose of opioids received in the postoperative period (at first 24 hours). 2. Time taken for the first dose of rescue analgesia. 3. To evaluate the incidence of any side effects: Respiratory depression, nausea, and vomiting, pruritus, the incidence of reintubation, sedation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years undergoing midline sternotomy for cardiac surgeries, New York Heart Association grade II-III patients.
排除标准
- •Patient refusal to consent, contraindications to intrathecal analgesia such as infection at the injection site, coagulopathy, and allergy to morphine, pre-existing chronic pain: taking routine analgesics, patients with a history of chronic opiate abuse, patients with psychiatric disorders, patients with previous surgery in thoracic vertebral region, preexisting neurological condition (spinal cord injury, multiple sclerosis, etc.), patients with BMI more than or equal to 35, patients with severe respiratory disease, those expected to be on elective mechanical ventilation for more than 6 hours postoperatively, patients with renal dysfunction (Serum creatinine more than 1.5 mg/dl).
结局指标
主要结局
To assess postoperative pain by visual analogue scale (VAS) score
时间窗: upto 24 hour post-operative period
次要结局
- Total dose of opioids received in the postoperative period (at first 24 hour)(upto 24 hour post-operative period)
- Time taken for the first dose of rescue analgesia(in first 24 hour post-operative period)
- To evaluate the incidence of any side effects such as respiratory depression, nausea and vomiting, pruritus, incidence of reintubation and sedation(upto 24 hour post-operative period)
研究者
Anil Gupta
All India Institute of Medical Sciences