A Comparative study: Intrathecal Nalbuphine versus Intrathecal Pentazocine as adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under Subarachnoid block
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the duration of postoperative analgesia provided by intrathecal nalbuphine and pentazocine when used as adjuvants to 0.5% hyperbaric bupivacaine
研究概览
简要总结
This is a prospective randomized double blinded study for a 2 year period to compare the effect of intrathecal nalbuphine and intrathecal pentazocine as adjuvants to 0.5 percent hyperbaric bupivacaine in patients undergoing infraumbilical surgeries under subarachnoid block. This study includes the comparison between the onset of time and duration of sensory and motor block between the two groups, assessment of intraoperative and postoperative hemodynamic parameters between the groups and evaluate the incidence of adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 giving informed consent ASA grade one or two Patients scheduled for elective lower abdominal, perineal, or lower limb surgeries.
排除标准
- •Patients not willing to participate in the study ASA grade three and above Patients with uncontrolled or labile hypertension, Diabetes Mellitus, psychiatric disorders, history of chronic low back pain, evidence of hepatic or renal dysfunction, known hypersensitivity to local anaesthetics or opioids.
结局指标
主要结局
To compare the duration of postoperative analgesia provided by intrathecal nalbuphine and pentazocine when used as adjuvants to 0.5% hyperbaric bupivacaine
时间窗: time(in minutes) to first rescue analgesia
次要结局
- To compare the onset time and duration of sensory and motor block between the two adjuvant groups.
- To assess and compare intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure) in both groups.
- To evaluate the incidence of adverse effects such as nausea, vomiting, hypotension, bradycardia, pruritus, and respiratory depression associated with each adjuvant.(Noted till 24 hours postoperatively)
研究者
Swathi Kilari
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research