A comparative study of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. onset and duration of sensory block level.
研究概览
简要总结
THIS STUDY WAS CONDUCTED IN RANDOMIZED, DOUBLE CONTROLLED MANNER ON A TOTAL OF 60 ASA GRADE I & II PATIENTS POSTED FOR TURP SURGERY UNDER SUBARACHANOID BLOCK USING BUPIVACAINE AS THE LOCAL ANAESTHETIC DRUG. THE DRUGS FENTANYL AND NALBUPHINE WERE USED AS ADJUVANTS TO BUPIVACAINE FOR COMPARATIVE EVALUATION OF EACH IN TERMS OF ONSET AND DURATION OF MOTOR AND SENSORY BLOCK AND CHANGES IN HAEMODYNAMIC PARAMETERS INTRAOPERATIVELY AS WELL AS POSTOPERATIVELY. ALSO, THE POSTOPERATIVE ANALGESIA AND SIDE EFFECT PROFILE IN BOTH THE GROUPS WERE RECORDED. ALL THE OBSERVATIONS WERE TABULATED AND SENT FOR STATISTICAL EVALUATION.
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
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •ASA grade I and II.
排除标准
- •ASA grade III or more
- •Patients refusal for subarachnoid block.
- •Patients on anticoagulant medication.
- •History of anaphylaxis to local anaesthetics.
- •Infection at site of injection.
- •patient with spinal deformities.
结局指标
主要结局
1. onset and duration of sensory block level.
时间窗: onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
2. onset and duration of motor block level.
时间窗: onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
3. evaluating haemodynamic parameters.
时间窗: onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
次要结局
- 1. Duration of post operative analgesia.(2. Side effect profile with each drug.)