To compare the efficacy of isobaric Ropivacaine 0.75 percent with isobaric Levobupivacaine 0.5 percent in spinal anaesthesia with inj Fentanyl as an adjuvant in patients posted for lower abdominal surgeries .
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of Duration of postoperative Analgesia between two groups isobaric levobupivacaine with fentanyl and isobaric ropivacaine with fentanyl
研究概览
简要总结
Title of the study project is **TO COMPARE THE EFFICACY OF ISOBARIC ROPIVACAINE AND ISOBARIC LEVOBUPIVACAINE IN SPINAL ANAESTHESIA WITH INJ FENTANYL AS AN ADJUVANT IN PATIENTS POSTED FOR LOWER ABDOMINAL SURGERIES.**In our study we want to compare the efficacy of intrathecal isobaric ropivacaine 0.75 percent 3ML with fentanyl 25 mcg 0.5ml and isobaric levobupivacaine 0.5 percent 3ml with fentanyl 25 mcg 0.5 ml as adjuvant for the quality of anaesthesia and postoperative analgesia in patients undergoing elective lower abdominal surgeries .Primary objective is to compare the characteristics of blockade and duration of post operative analgesia between two groups.Secondary objectives are Comparison with respect to haemodynamic parameters and Comparison with respect to adverse effects and complications This study will be conducted at Smt Kashibai Navale Medical College and General Hospital Pune. After taking informed written consent, patients aged between 18 to 65 years of either sex will be randomly allocated into two groups using computer generated random number tables as Group RF in which patients will receive Intrathecal isobaric Ropivacaine 0.75 percent 3 ml with inj fentanyl 25mcg 0.5 ml andGroup LFwill receive Intrathecal hyperbaric Levobupivacaine 0.5 percent 3 ml with inj fentanyl 25mcg 0.5ml.Our hypothesis is that both sensory and motor blockade will be better with levobupivacaine as compared to ropivacaine and adding fentanyl as an adjuvant will increase the duration of postoperative analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •1.ASA I &II patients 2.Patients posted for elective lower abdominal surgeries under spinal anaesthesia.
排除标准
- •1.Patient refusal 2.Contraindication to subarachnoid block.
- •3.Central or peripheral neuropathies 4.Patients with bleeding disorders and those on anticoagulant therapy.
- •5.History of allergy to local anaesthetics.
- •6.Infection at site of block.
- •7.Obesity 8.Pregnant women.
- •9 Patients with psychiatric behaviour
- •History of chronic opioid use.
结局指标
主要结局
Comparison of Duration of postoperative Analgesia between two groups isobaric levobupivacaine with fentanyl and isobaric ropivacaine with fentanyl
时间窗: from the time of administration of study drug intrathecally to the patient complaint of pain postoperatively or VAS more than 3 postoperatively till 24 hours.
次要结局
- Comparision of hemodynamic stability between two groups isobaric ropivacaine with fentanyl and isobaric levobupivavaine with fentanyl(from the administration of drug in spinal till completion of surgery and postoperative till 24 hours)
- Comparision of adverse effects between two groups isobaric ropivacaine with fentanyl and isobaric levobupivavaine with fentanyl(from the administration of drug in spinal till completion of surgery and postoperative till 24 hours)