CTRI/2025/03/081915招募中2/3 期
Comparison of hemodynamic disturbances and postoperative analgesia between intrathecal bupivacaine with buprenorphine as adjuvant and intrathecal bupivacaine alone in lower segmental caesarean section: A randomised controlled study
Dr Koushik Baran Roy1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年3月31日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Duration of postoperative analgesia
研究概览
简要总结
This study is a prospective, double blinded, parallel group, randomized controlled, tertiary centre trial comparing the duration and efficacy of postoperative analgesia between preservative free low dose (60 mcg) intrathecal buprenorphine hydrochloride as adjuvant to (10 mg) 0.5 percent hyperbaric bupivacaine versus (10 mg) intrathecal 0.5 percent hyperbaric bupivacaine alone to determine the better effective study arm in terms of achieving better postoperative analgesia and patient satisfaction with least side effects in women undergoing elective caesarean section.
The primary outcome will be the total duration of postoperative analgesia.
The secondary outcomes will be the followings-
- Hemodynamic response
- Complications (eg. pruritus, nausea and/or vomiting, respiratory depression)
- 24-hour postoperative pain (Visual Analogue Score)
- Level of Sedation (Ramsay Sedation Score)
- APGAR score (status of the neonate)
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term (more than 37 weeks) pregnant women, Pregnant women (ASA grade II including women with mild PIH and controlled gestational diabetes) posted for elective caesarean section under spinal anaesthesia, Patients willing for elective caesarean section, Those who can give valid informed written consent for participation.
排除标准
- •Patients not willing to give consent, Known allergy to amide local anaesthetics and buprenorphine, Patients with contraindications to subarachnoid block, patients with.
- •cardiovascular disease, severe preeclampsia, uncontrolled gestational diabetes, preexisting neurological disease Deformities of spinal column in severe degree, Less than 18 years or more than 35 years of age, ASA grade III and above, Failed spinal anaesthesia, Antepartum haemorrhage, Morbid obese (BMI more than equals to 40).
结局指标
主要结局
Duration of postoperative analgesia
时间窗: From the time of end of surgery till the first demand of rescue analgesic.
次要结局
- Heart Rate(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours.)
- Systolic Blood Pressure(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Diastolic Blood Pressure(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Mean Arterial Pressure(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Oxygen Saturation (SPO2)(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Respiratory Rate(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- APGAR Score (Neonatal status)(At 1 min,then 5 min after delivery)
- Visual Analogue Score (Level of pain)(Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours.)
- Ramsay Sedation Score (Level of sedation)(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Pinprick method (Level of sensory block)(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours (till 2 segment regression from maximum level))
- Modified Bromage Score (Level of motor block)(Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours)
- Pruritus(From the time of intrathecal injection till 24 hours after surgery.)
- Nausea(From the time of intrathecal injection till 24 hours after surgery.)
- Vomiting(From the time of intrathecal injection till 24 hours after surgery.)
- Total amount of vasopressor required(From the time of intrathecal injection till 24 hours after surgery.)
- Total no. of topup rescue analgesic required(From the time of intrathecal injection till 24 hours after surgery.)
- Shivering(From the time of intrathecal injection till 24 hours after surgery.)
研究者
Dr Koushik Baran Roy
ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital
研究点 (1)
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