Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia: A Prospective Randomised Double-Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 主要终点
- Primary outcome
研究概览
简要总结
In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale
详细描述
Hours prior to surgery
- All the patients included in the study will be explained in detail about the purpose of the study, need, benefits and risks of procedure.
- They will be instructed on the method used for sensory and motor assessments.
- In addition, they will be explained about numerical rating scale of pain, how to use it and rate it and about symptoms of the visceral pain (if any) during SAB in intraoperative period.
- Written informed consent will be obtained during pre-anaesthetic check-up.
- Fasting period will be ensured before taking to pre-operative room.
- Premedication will be done with Tab. Pantoprazole 40 mg and Tab. Metoclopramide 10 mg at 10 pm the day before surgery and 6 am in morning of surgery will be ensured.
Before surgery
- In pre-operative room, a peripheral intravenous (IV) line will be established with 18-G IV cannula.
- Preloading will be done with 10 ml/kg of Lactated Ringer's solution.
- Baseline blood pressure, mean arterial pressure, heart rate, respiratory rate, SpO2, fetal heart rate will be recorded in pre-delivery room.
In the operation theater:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective caesarean deliveries under SAB
- •ASA PS II
- •Age ≥18 years
- •Term pregnancy ≥37 weeks of gestation
- •Height ≥ 150
排除标准
- •Patients with medical disorder in pregnancy (neurological, psychiatric, cardiopulmonary,
- •hepatorenal diseases, coagulopathy)
- •Patient refusal to participate
- •Allergy or hypersensitivity to LA, fentanyl or dexmedetomidine
- •Patients with communication problem
- •Patient with bradycardia (HR- less than 60)
研究组 & 干预措施
Bupivacaine with Fentanyl (BF)
In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml . Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.
干预措施: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine (Drug)
Bupivacaine with Dexmedetomidine (BD)
In patients undergoing elective LSCS under subarachnoid block, group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.
干预措施: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine (Drug)
结局指标
主要结局
Primary outcome
时间窗: Intraoperative
To compare the incidence of intraoperative visceral pain between participants of two groups.
次要结局
- Secondary Outcome(Intraoperative)
研究者
Sujan Dhakal, MD
Consultant Anaesthesiologist
Tribhuvan University Teaching Hospital, Institute Of Medicine.