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临床试验/CTRI/2024/05/067462
CTRI/2024/05/067462
尚未招募
Phase 3 4

Comparison Of Analgesic Efficacy Of Intra-Operative Intravenous Nefopam Paracetamol Combination Versus Intravenous Tramadol Paracetamol Combination On Post Operative Analgesia Among Patients Posted For Laparoscopic Cholecystectomy Under General Anaesthesia “– Randomised Double Blinded Study

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月25日最近更新:

概览

阶段
Phase 3 4
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Reduction in VAS scores Expected to be better with Inj Nefopam Paracetamol combination than Tramadol paracetamol combination

概览

简要总结

Though Laparoscopic Cholecystectomy is a minimally invasive procedure ,the incidence of Significant post operative pain is estimated to be 50-70% . Control of post operative pain still remains a challenge which otherwise causes morbidity in the form of impaired pulmonary function, stress, nausea , vomiting , increased cardiac demand , prolonged hospital stay , delayed mobility etc. many drugs from different groups including opioids have been tried to alleviate this pain but significant side effects of opioids limit the liberal usage of the same and any single group of drug has not been proven to be effective in complete pain relief. The International Association for the Study of Pain (IASP)[2] differentiated types of pain and noted its chemical mediators that transduce and transmit the pain through different type and sizes of nerve  fibres that had led to co-administration of combination of analgesics that have different mechanisms of action through a strategy called “multimodal”[5] or “balanced analgesia .Hence, Selecting drugs from different  groups which act through different mechanism to alleviate the post operative pain seems logical.In this study we intend to study the efficacy of Intravenous  Paracetamol Nefopam and intravenous Paracetamol Tramadol combinations in providing the post operative analgesia in adult patients posted for laparoscopic cholecystectomy under general anaesthesia .

After clearance from Ethical committee 50 Patients will be recruited and devided into 2 groups. Patients in Group A will receive infusion of inj Nefopam 0.3mg/kg along with Paracetamol 15mg/kg in 100ml normal saline over 10-15 minutes and Group B patients will receive  Infusion of inj Tramadol 1mg/kg along with Paracetamol 15mg/kg in 100 ml normal saline over 10-15 mins , 15 minutes prior to the completion of surgery .Post–operatively  pain will be assessed using Visual Analogue Score (VAS ) at 0th min , at 5mins , 15mins , 30mins , 1st hour , 2nd hour , 6th hour ,12 hours and 24th hour . Rescue analgesics will be used if VAS score is ≥ 4.  Total consumption of Rescue Analgesic in the first 24 hours post-operative period will be noted.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Aged 18-60yrs 2.American society of Anaesthesiologist (ASA ) physical status grade 1,2 3.Posted for elective and emergency laparoscopic cholecystectomy under General Anaesthesia(GA).

排除标准

  • 1.Refusal to Enrol for the study 2.known allergy to study drug , 3.K/c/o epilepsy , psychiatry disorders , opioid dependence and 4.Patients on current use of analgesics 5.Laparoscopic surgery later converted into open technique.

结局指标

主要结局

Reduction in VAS scores Expected to be better with Inj Nefopam Paracetamol combination than Tramadol paracetamol combination

时间窗: Assessment of Post-operative Pain using VAS scores at 0th min , 5mins , 15mins , 30mins , 1st hour , 2nd hour , 6th hour ,12 hours and 24th hour

次要结局

  • To Compare The Consumption Of Rescue Analgesics In The First 24 Hours Of Post-Operative Period .(First 24 hours)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Basavaraj Padara

Department of Anaesthesia , S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102

研究点 (1)

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