A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pain as measured with Visual analogue scale
研究概览
简要总结
The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects
详细描述
Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 & 2, posted for elective lower limb orthopedic surgeries Exclusion criteria
- Sepsis at the site of injection
- Coagulopathy
- Patients with history of renal, hepatic, cardiovascular disease
- Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor) The assessor of the outcome would measure hemodynamic parameters and severity of the pain at the mentioned time intervals. The assessor was not involved in the randomization / administration of the intervention
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 & 2
- •Posted for elective lower limb orthopaedic surgeries
排除标准
- •Sepsis at the site of injection
- •Coagulopathy
- •Patients with history of renal, hepatic, cardiovascular disease
- •Patient on chronic opioid use
研究组 & 干预措施
Paracetamol
Paracetamol is one of the most frequently used analgesic and antipyretic agent, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDS.
干预措施: Tapentadol Hydrochloride (Drug)
Tapentadol
Tapentadol is a novel, centrally acting analgesic with dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition.this dual mode of action is responsible for its opioid sparing effect, which contributes to reduction in some of the typical opioid related adverse effects
干预措施: Tapentadol Hydrochloride (Drug)
结局指标
主要结局
Pain as measured with Visual analogue scale
时间窗: Every 12 hours after the intervention till about 72 hours after the intervention
The pain rating was done as per a visual analogue scale (VAS) of 0-100 (score 0 = no pain, score 100 - most severe pain). Patients with a VAS score of more than 30, at what is considered as base line, in group A=received IV paracetamol 1gm given every 5-6 hourly and in group B=received intranasal tapentadol 44.5mg nasal spray administered every 5-6 hourly. Patient was assessed for pain by using VAS half an hour after administration and the scores were documented. Pain score were recorded at and after 30 minutes of the intervention in the following time frames - 12hr,24hr,36hr,48hr, 60hr and 72hrs after the baseline intervention (0hr).
次要结局
- The need for rescue analgesia(In the first 72 hours after the initiation of the intervention)
研究者
Priyanka Suresh
Assistant Professor
Kempegowda Institute of Medical Sciences, Bangalore