To compare the safety and efficacy of flupertine maleate, tapentadol hydrochloride and tramadol hydrochloride for post operative analgesia in lower abdominal surgeries under spinal anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare efficacy of Flupirtine maleate, Tapentadol
研究概览
简要总结
This study will be conducted in prospective, randomized double blind manner in Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar in department of anaesthesia and critical care. Introduction: Pain following surgery is an unwanted effect which is to be relieved for the better outcome of surgery and anaesthesia. Flupirtine maleate, Tapentadol Hydrochloride and Tramadol hydrochloride are effective analgesics with minimal side effects. The study will be conducted to compare the efficacy and safety of the study drugs for post-operative pain relief in lower abdominal surgeries performed underspinal anaesthesia. Materials And Methods: The study will be done on 120 patients of American Society of Anaesthesiologist (ASA )grade I and II grades aged 18-60 years. Group A will receive - 100 mg of Flupirtine Maleate tablet orally, Group B will receive 50 mg of Tapentadol Hydrochloride tablet orally. Group C will receive 50 mg of Tramadol Hydrochloride tablet orally. Pain intensity will be analysed by visual analogue scale (VAS ). Study drugs will be given initially after 3 hours of start of surgery. Patients will be assessed 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours. Subsequent doses will be given after evaluation of VAS, only if VAS >3 at an interval of minimum 6 hours. Sedation will be assessed with the Modified Wilson sedation scale after 1 hour and 2 hour of giving the study drug. Safety and tolerability will be assessed by side effects reported by patients and after 48 hours the liver function tests will be assessed again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Physical status based on ASA Grade 1 and Grade
- •2 Patients posted for lower abdominal surgeries under spinal anaesthesia.
- •appendicectomy, herniorrhaphy, hernioplasty,, excision of lipoma, fistulectomy, haemorrhoidectomy, hydrocoele, varicocoele, Perianal abscess drainage,fissurectomy etc.
排除标准
- •1.Patients with uncontrolled co-existing systemic or metabolic diseases.
- •Patients with any liver disease
- •Pregnant and lactating women.
- •Patients with narcotic addiction.
- •Patients with known hypersensitivity to the study drugs
- •Patient’s refusal.
结局指标
主要结局
To compare efficacy of Flupirtine maleate, Tapentadol
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
hydrochloride and Tramadol hydrochloride for post operative analgesia in lower
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
abdominal surgeries performed under spinal anaesthesia in terms of
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
1. Duration of analgesia after the study drug is given
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
2. Frequency of doses required of the study drug
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
3. VAS assessment
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
4. Frequency of rescue analgesia
时间窗: after 3 hours of start of surgery, after that 3 hourly for first 12 hours and 6 hourly thereafter till 48 hours.
次要结局
- Incidence of adverse effects during the study period(after 3 hours of start of surgery, till 48 hours.)
研究者
Dr Lakshmi Mahajan
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
