A PROSPECTIVE,RANDOMISED, DOUBLE BLINDED COMPARATIVE STUDY BETWEEN 0.5% BUPIVACAINE AND 0.5% BUPIVACAINE WITH PENTAZOCINE AS AN ADJUVANT IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR POST OPERATIVE ANALGESIA IN UPPER LIMB SURGERY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- We are expecting that 0.5% bupivacaine with pentazocine as an adjuvant will increase duration of sensory and motor blockade and will provide better analgesia than 0.5% bupivacaine alone
研究概览
简要总结
Aprospective,randomised,double blinded comparative study between 0.5%bupivacaine and 0.5% bupivacaine with pentazocine as an adjuvant insupraclavicular brachial plexus block for post operative analgesia in upperlimb surgery
Our objective is tocompare the intraoperative effect , hemodynamic stability and post operativeanalgesia duration and side effects between 0.5% bupivacaine and0.5% bupivacaine with pentazocine as an adjuvent in supraclavicular brachialplexus block .
This is a hospital based,prospective, randomized, placebo-controlled, double blind,analytical study on cohort of patients posted for elective upperlimb surgery under supra clavicular brachial plexus block in general surgeryand orthopedics operation theatre and PACU of Midnapore Medical College overthe period of 18 months
We are expecting that 0.5%bupivacaine with pentazocine as an adjuvant will increase duration of sensoryand motor blockade and will provide better analgesia than 0.5% bupivacaine alone on 70 patient posted for upper limb surgery .
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
- •Age between 18-60 years
- •ASA grade 1 & 2
- •Elective upper limb Surgery under supraclavicular brachial plexus block.
排除标准
- •Patients with history of Uncontrolled Diabetes-Mellitus Uncontrolled Hypertension Coagulopathy Liver disease Cardio pulmonary disease Renal insufficiency or failure Musculoskeletal disorder Drug and alcohol abuse
- •Pregnant patients
- •BMI more than 30
- •Allergy to bupivacaine or pentazocine
- •Conversion to general anesthesia
- •Brachial plexus block failure
- •Difficult airway
- •Surgeries with intraoperative time more than 2 hours.
- •Patient who received analgesic in the pre operative phase (within effective time range of that particular drug)
- •Unwilling to participate
- •Serology positive (HIV1&2,Hbs ag,Anti HCV), & immunocompromised patients.
结局指标
主要结局
We are expecting that 0.5% bupivacaine with pentazocine as an adjuvant will increase duration of sensory and motor blockade and will provide better analgesia than 0.5% bupivacaine alone
时间窗: Patient’s hemodynamic profile (like BP, heart rate, oxygen saturation etc), pain , and adverse effects will be monitored at base line, just after giving block then every 15 minutes intra operatively and every hour postoperatively for 8 hours.
次要结局
- 1.To compare the hemodynamic changes like Heart rate(HR), Systolic Blood Pressure(SBP),(Diastolic Blood Pressure(DBP),Mean Arterial Pressure(MAP) intra and post operatively)