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临床试验/CTRI/2024/04/065076
CTRI/2024/04/065076尚未招募2/3 期

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

Sri Guru Ram Das Institute of Medical Sciences and research1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月12日最近更新:

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

发起方
Sri Guru Ram Das Institute of Medical Sciences and research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lakshmi Mahajan

Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar

研究点 (1)

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