A prospective, open label, randomized, non-comparative, multicentric study to evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pain
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Proportion of patients who required rescue analgesia
研究概览
简要总结
Combined use of the Bupivacaine and Fentanyl Citrate in the treatment of post-operative pain and in labour pain is well established in India. There are number of published Clinical Studies concluding the effectiveness and safety of combined administration of Bupivacaine 1.25 mg/ml + Fentanyl Citrate 2 μg/ml as Epidural Injection, by academic institutions in India, for the control of post-operative pain in more than 228 patients collectively and for the control of labour pain in more than 170 parturient women collectively.
Moreover, the fixed dose combination of the Bupivacaine + Fentanyl Citrate is already approved in United Kingdom, New Zealand and Switzerland since 5 to 10 years, for epidural analgesia during labour and post-operative pain, by administration as bolus, continuous infusion as well as intermittent boluses.
Based on this information, Troikaa has proposed the clinical trial of fixed dose combination of Bupivacaine + Fentanyl Citrate solution for epidural injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Physical Status Class I or II Patients undergoing elective surgery with a.
- •A plan to have epidural catheter for analgesia.
- •If patients are female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study Parturient in active labour with: a.
- •A cervical dilation of 3–6 cm requesting epidural analgesia.
- •Parturient having full-term live fetus, without any complications.
排除标准
- •Recent (within last 6 months) history of thromboembolic event e.g. Pulmonary embolism, deep vein thrombosis, superficial thrombophlebitis treated surgically Criteria includes multiple or preterm gestation pregnancies or weight >130 Kg Anticipated difficultly intubation Any contraindication for epidural catheter placement Hepatic impairment (SGPT/OT > 3 times ULN) or renal impairment (creatinine > 2 mg/dL) Known hypersensitivity to bupivacaine, fentanyl or diclofenac Presence of or susceptibility to respiratory depression Hypovolemia or complete heart block.
结局指标
主要结局
Proportion of patients who required rescue analgesia
时间窗: VAS at 30 and 45 minutes compared to baseline
Mean change in pain intensity on VAS at 30 and 45 minutes compared to baseline
时间窗: VAS at 30 and 45 minutes compared to baseline
次要结局
- Onset of analgesia(Percentage of patients requiring rescue analgesia)