Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Postoperative pain at 30 minutes
研究概览
简要总结
To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.
详细描述
Control group (current analgesia, elective CS) is compared to current analgesia for emergency CS, and guideline recommended analgesia.
Current analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative: Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2 po, additional oxycodone 2,5 mg iv/5 mg po when needed.
Guideline recommended analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05 mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy parturient, term pregnancy, undergoing caesarian section
排除标准
- •Patient refusal
- •Maternal heart or lung disease (not including mild asthma)
- •Known or suspected obstructive sleep apnoea syndrome
- •Pre-eclampsia
- •Body mass index > 40
- •Indulin-dependent diabetes mellitus
- •Contraindications to ibuprofen, dexamethasone or morphine
- •Chronic pain
- •Neurological disease
- •Drug abuse
- •Age < 18 years
- •American Society of Anesthesiologists (ASA) 3
- •Patients receiving other forms of anaesthesia (epidural or general)
研究组 & 干预措施
Control group
Elective CS patients receiving current analgesia.
干预措施: Bupivacaine-fentanyl elective group (Drug)
Intervention group
Elective CS patients receiving guideline recommended analgesia.
干预措施: Bupivacaine-fentanyl-morphine elective group (Drug)
Emergency group
Emergency CS receiving current analgesia.
干预措施: Bupivacaine-fentanyl emergency group (Drug)
结局指标
主要结局
Postoperative pain at 30 minutes
时间窗: At postoperative care unit 30 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 60 minutes
时间窗: At postoperative care unit 60 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 8 hours after arrival
时间窗: At maternity ward 8 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 12 hours after arrival
时间窗: At maternity ward 12 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward arrival
时间窗: Immediately upon arrival at maternity ward
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 16 hours after arrival
时间窗: At maternity ward 16 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at postoperative care unit arrival
时间窗: Immediately upon arrival at postoperative care unit
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 90 minutes
时间窗: At postoperative care unit 90 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 120 minutes
时间窗: At postoperative care unit 120 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 4 hours after arrival
时间窗: At maternity ward 4 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 20 hours after arrival
时间窗: At maternity ward 20 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
次要结局
- Postoperative nausea and vomiting at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative pruritus at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative additional oxycodone consumption at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative pruritus at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
- Postoperative additional oxycodone consumption at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
- Postoperative nausea and vomiting at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
研究者
Conrad Arnfinn Bjørshol
Senior researcher
Helse Stavanger HF