A Comparative Study to evaluate the efficacy between Ropivacaine 0.75% with Nalbuphine and Bupivacaine 0.5% with Nalbuphine in Spinal Anaesthesia for Percutaneous Nephrolithotomy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the onset, duration and intensity of spinal anaesthesia as well as duration of postoperative pain relief.
研究概览
简要总结
Thisprospective randomized study will be conducted on patients undergoing PCNLunder spinal anaesthesia (SA). Patients will be randomized by simple randomsampling into two groups, n=40, after verifying the inclusion an exclusioncriteria. This study will compare the onset, duration and intensity of SA,duration of postoperative pain relief as well as intraoperative hemodynamicchanges and incidence of complications when either hyperbaric ropivacaine 0.75%or hyperbaric bupivacaine 0.5% is combined with 2mg nalbuphine in spinalanaesthesia used for PCNL. This study will guide to select better drugcombination and drug profile for PCNL which will be beneficial to the patient.With the use of either ropivacaine with nalbuphine or bupivacaine withnalbuphine in SAB for PCNL, it is expected to have hemodynamic stability,decrease complications, decrease PONV, decrease post-operative pain and alsodecrease length of hospital stay.
Oncepatient is shifted to the operating room, ASA standard monitor will beconnected and baseline BP, HR, Sp02 will recorded and monitored throughout theprocedure. Both groups will receive SA in sitting position in L2-L3intervertebral space using 27G Quincke spinal needle.
Group-R(n=40):Ropivacaine group=3.2 ml 0.75% Ropivacaine (heavy) + 2mg Nalbuphine
Group-B(n=40):Bupivacaine group=3.2 ml 0.5% Bupivacaine (heavy) + 2mg Nalbuphine
Sensoryblockade will be evaluated every 30 seconds and motor blockade will be assessedby Modified Bromage scale till the block height of T6 is attained.
Allpatients will be monitored with non-invasive multiparameters (SBP, DBP, MAP,HR) every two minutes for the first 10 minutes than every five minutes duringand till the end of the surgery and every 20 minutes in the Post-AnaestheticCare Unit (PACU).
Patientswill be observed for 24 hrs for pain with NRS scoring (0-10, 0=No pain &10= Worst pain).
Patientswill be also observed and noted for any postoperative complications like nausea,vomiting, hypotension (SBP≤ 90mmhg), bradycardia (PR≤ 60/min), back pain and posturalheadache. The complications will be treated with appropriate measures.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing elective PCNL ASA physical status I & II.
排除标准
- •Patient’s refusal Patient with known allergy to the drugs used in the study Hemodynamic instability.
- •Coagulopathy Patients with significant cardiac, respiratory and hepatic dysfunction •Spinal deformity •Local infection at injection site.
结局指标
主要结局
To compare the onset, duration and intensity of spinal anaesthesia as well as duration of postoperative pain relief.
时间窗: Intraoperative and 24hrs postoperative
次要结局
- Intraoperative hemodynamic changes and incidence of complications.(Intra-operative)
