A prospective randomized comparative study of intrathecal Nalbuphine vs Fentanyl as an adjuvant to 0.5% Hyperbaric Bupivacaine in below umbilical surgeries
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess and compare the duration of post operative analgesia of Nalbuphine and Fentanyl as an adjuvant to 0.5 % Hyperbaric bupivacaine as intrathecal anesthesia in infra-umbilical surgeries.
研究概览
简要总结
Patients posted for infra umbilical electivesurgeries under spinal anesthesia.Participants will be selected as per the inclusion and exclusioncriteria and consecutively enrolled into the study till the targeted samplesize is achieved. Randomization will bedone to allocate the participants into the two groups. Block randomization willbe done with the help of external person not involved in the study(epidemiology unit of community medicine department).The proposed study will be a double blindedrandomized study. The nalbuphine 1mg or fentanyl (25mcg) as an adjuvant alongwith 0.5%hyperbaric bupivacaine will be given to the patient by ananesthesiologist who is not involved in thestudy via intrathecal route. He/ Shewill administer the drug intrathecally according to the code received by thepatient. The investigator who records the data will not be aware of theparticipant’s group. The participant will not know to which group he/she isbeing allotted. Sequence will be handed over to the principal investigator insealed envelope. Decoding will be done by the statistician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •patients posted for elective infra-umbilical surgerY under ASA physical status 1 & 2.
排除标准
- •Body Mass Index >
- •Patients with local site infection, allergy to the drugs that are tested or any other contraindications for spinal anesthesia.
- •Patients who cannot lie down/ non co-operative/ psychiatric illness.
- •Alcoholics.
- •Pregnant / Lactating women.
- •Patient having failed spinal, transformed into general anesthesia will be excluded from study.
- •Patients refusal for participation in the study.
- •Patients with height less than 150 cm.
结局指标
主要结局
To assess and compare the duration of post operative analgesia of Nalbuphine and Fentanyl as an adjuvant to 0.5 % Hyperbaric bupivacaine as intrathecal anesthesia in infra-umbilical surgeries.
时间窗: Duration of post operative analgesia assessed for every 30 minutes for 4hours
次要结局
- To assess and compare the onset and duration of sensory blockade and motor blockade.(To assess and compare the hemodynamic parameters.)