Comparision of Post Operative Analgesia Between Nalbuphine and Fentanyl as adjuvant with intrathecal Levobupivacaine for lower abdominal Gynaecological 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
- We are trying to prove the hypothesis that addition of adjuvant 1 mg Inj.Nalbuphine intrathecally to Hyperbaric Levobupivacaine prolongs the duration of post-operative analgesia more as compared 25mcg Inj.Fentanyl intrathecally with hyperbaric levobupivacaine
研究概览
简要总结
Spinal anaesthesiahas a rapid onset and complete motor blockade and also simple to perform.It has lower incidence of failed block and the local anaesthetic requirement isless. Hence spinal anesthesia is a preferred anaesthetic technique for lowerabdominal surgeries. Adjuvants to local anaesthetics for intrathecaladministration has some advantages. They have synergistic action & intensify sensory block without increasing sympathetic block, reducedlocal anaesthetic drug dose, better hemodynamic stability with lesser sideeffects.
Fentanyl is a pure mu receptor agonist. The common mu agonist sideeffects are nausea, vomiting, sedation, urinary retention andrespiratory depression. It is lipophilic in nature, with rapid onset of action following intrathecaladministration. The intrathecal drug administration does not producerespiratory depression. It improves anaesthetic quality without muchcomplications. Nalbuphine is a mixedkappa agonist and mu antagonist opioid drug, which produces analgesia withoutmuch side effects of mu receptor agonist action.
Levobupivacaine is alocal anaesthetic amide which can produce better sensory and motor block withgood hemodynamic profile than bupivacaine. Levobupivacaine is less cardiotoxic than bupivacaine. (1) Many investigators have studied the characteristics of intrathecalnalbuphine & fentanyl with levobupivacaine.
The purpose of this study is to compare the efficacy of fentanyl & nalbuphine as adjuvants to intrathecal levobupivacaine for post-operativeanalgesia following lower abdominal gynaecological surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1Age between 35-75 years 2Lower Abdominal surgeries under Subarachnoid Block 3Duration of Surgery 2 hours 4ASA I & II 5MPC I & II 6Patients willing to participate in the study.
排除标准
- •1Lack of valid informed written consent 2ASA grade III and IV 3Infection at the subarachnoid block injection site 4Patients with neurological and musculoskeletal disease 5Patients with bleeding disorders 6Patients on anticoagulants 7History of allergy to local anesthetic, Fentanyl and Nalbuphine.
结局指标
主要结局
We are trying to prove the hypothesis that addition of adjuvant 1 mg Inj.Nalbuphine intrathecally to Hyperbaric Levobupivacaine prolongs the duration of post-operative analgesia more as compared 25mcg Inj.Fentanyl intrathecally with hyperbaric levobupivacaine
时间窗: post operative analgesia will be assessed as the primary outcome and it will be monitored for 2 hrs post spinal anaesthesia
次要结局
未报告次要终点
