An Observational study of comparison of Isobaric Ropivacaine 0.75% with Tramadol and Isobaric Ropivacaine 0.75% with Nalbuphine intrathecally in infra-umbilical surgeries
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- This observational study will help us to evaluate whether Ropivacaine with Tramadol or Ropivacaine with Nalbuphine intrathecally is better for infra-umbilical surgeries
研究概览
简要总结
An Observational study of comparison of Isobaric Ropivacaine 0.75% with Tramadol and Isobaric Ropivacaine 0.75% with Nalbuphine intrathecally in infra-umbilical surgeries
**AIM:**The aim of this study is to compare the effect of addition of nalbuphine 1 mg to isobaric ropivacaine 0.75% and tramadol 25mg to isobaric ropivacaine 0.75% on onset and duration of sensory and motor blockade, hemodynamic stability, duration of postoperative analgesia and complications if any in patients undergoing infra-umbilical surgeries
OBJECTIVES:
The objectives are:
1) To compare onset of sensory and motor blockade
2) To compare duration of sensory and motor blockade
3) To compare the changes in pulse rate, blood pressure, oxygen saturation and respiratory rate
4) To compare duration of analgesia
5) To compare side effects/complications if any
6) To compare number of rescue analgesia required in 24 hours
STUDY AREA: SBKS MEDICAL INSTITUTE AND RESEARCH CENTRE, SUMANDEEP VIDYAPEETH, PIPARIA, WAGHODIA, VADODARA, GUJARAT.
DESIGN OF STUDY: Observational study
GROUP T- Patients receiving Isobaric Inj.Ropivacaine 0.75% 3.5 ml + Inj tramadol(25mg) 0.5 ml
GROUP N- Patients receiving Isobaric Inj.Ropivacaine 0.75% 3.5 ml +1 mg Inj. Nalbuphine(0.1 ml)diluted till 0.5 ml with Sterile NS.
LIKELY OUTCOME /BENEFITS OF STUDY
This observational study will help us to evaluate whether Ropivacaine with Tramadol or Ropivacaine with Nalbuphine intrathecally is better for infra-umbilical surgeries. We will be able to know which drug is better in view of post-operative analgesia with minimum hemodynamic stability and less side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to sign informed consent.
- •ASA I & ASA Ill patients undergoing infraumbilical surgeries.
- •Patients in the age between 18- 65 years.
- •No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type and to opioids.
排除标准
- •Patient refusal.
- •Allergy to any drugs.
- •History of seizure disorder.
- •Known allergy to trial drug.
- •Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
- •ASA III, IV, Patients.
- •Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities).
结局指标
主要结局
This observational study will help us to evaluate whether Ropivacaine with Tramadol or Ropivacaine with Nalbuphine intrathecally is better for infra-umbilical surgeries
时间窗: level of sensory block assessed at 2 and 5 min post injection and at 5 min interval till 15 minutes. | onset of sensory block and duration of sensory block. | assessment of motor blockae using bromage scale,time of onset(time from from intrathecal injection to chieve grae 1 motor block)and Duration of sensory block(time from intrathecal injection to reurn of sensation at L1) | assessment of motor blockade using time of onset and duration of motor block
次要结局
未报告次要终点
研究者
Dr Suhani Jain
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre