Comparison of two different doses of intrathecal Morphine as an adjuvant to 0.5% heavy Levobupivacaine for postoperative analgesia in patients undergoing Total knee replacement.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. To compare the duration of post operative analgesia amongst two groups using Visual Analogue Scale(VAS) score.
研究概览
简要总结
After getting clearance from Institute Ethics Committee and written informed consent, patients planned for Total Knee Replacement, will be included in this study.
Using a computer generated random number table, patients will be randomly allocated to 2 groups each comprising of 35 patients. After ensuring double blinding-
Group A will receive SAB with morphine 100 mcg + Levobupivacaine(heavy) 15 mg, and
Group B will receive SAB with morphine 200 mcg + Levobupivacaine(heavy) 15 mg.
An epidural catheter will then be placed in all patients which will be activated at the time of demand for first rescue analgesic.
After that postoperative pain will be assessed at 0, 2hr, 4hr, 8hr, 12hr, 16hr, 24hr using Visual Analogue Scale.
When VAS>/= 4, rescue analgesic (Inj PCM 1gm i.v. + Epidural top up with 0.2% Ropivacaine 8ml + Tramadol 100mg) will be given.
Onset and duration of both, sensory and motor block will be noted.
Intra-operative hemodynamic monitoring will be done every 5 min and post-operatively at 2hr, 4hr, 8hr. 12hr, 16hr, 24hr.
Adverse effects like Post-operative nausea and vomiting, pruritis, urinary retention, constipation and respiratory depressions will be noted upto 24 hrs postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age from 18 to 75 yrs
- •All genders
- •ASA Physical status I – III
- •All patients placed for Elective Total Knee Replacement under Spinal Anaesthesia.
排除标准
- •Uncontrolled co-morbidities like hypertension, Diabetes, Heart Disease
- •Opioid addicts
- •Patients already on opioids.
- •All contraindications for spinal anaesthesia.
- •Pregnant and Lactating females.
- •Mentally retarded.
结局指标
主要结局
1. To compare the duration of post operative analgesia amongst two groups using Visual Analogue Scale(VAS) score.
时间窗: 0, 2hr, 4hr, 8hr, 12hr, 16hr, 24hr
2. To compare time to first rescue analgesic in both groups.
时间窗: 0, 2hr, 4hr, 8hr, 12hr, 16hr, 24hr
次要结局
- 1. Comparison of effect on Onset and Duration of Sensory and Motor Block in both group(2. Peri-operative hemodynamic monitoring- HR, BP, RR, SpO2 within 24 hrs)
研究者
Dr Shubhangi Agrawal
Mahatma Gandhi Medical College and Hospital