To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The efficacy of pain management
研究概览
简要总结
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding.
详细描述
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols:
- Oral pain relievers' administration in fix protocol without need for patient demand
- Spinal morphine given during the spinal anesthesia in the cesarean section
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women that underwent cesarean section with sinal anesthesia
排除标准
- •Women who suffer from chronic pain
- •Women using chronic pain medications
- •Women with allergy to any drug used in the study
- •Women underwent general anesthesia during the surgery
- •Women who suffer from sleep apnea
- •Women who suffer from obesity (BMI>40)
- •Women who suffer from severe nausea and vomiting after previous surgery
- •Women who received perioperative magnesium
- •Women who suffer from hypertension
- •Women who suffer from renal failure
研究组 & 干预措施
Fix protocol - Oral treatment
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day.
干预措施: Tramadol hydrochloride (Drug)
Fix protocol - Oral treatment
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day.
干预措施: Paracetamol (Drug)
Fix protocol - Oral treatment
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day.
干预措施: Diclofenac (Drug)
Fix protocol - Oral treatment
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day.
干预措施: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG) (Drug)
Spinal morphine
The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section
干预措施: Morphine (Drug)
结局指标
主要结局
The efficacy of pain management
时间窗: during 48 hours from surgery
Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain
次要结局
- Patient satisfaction(48 hours after surgery)
- The efficacy of pain management during 4 days past surgery(during 4 days past surgery)
- The necessity of additional medications (rescue doses)(During 48 hours after surgery)
- Adverse effect of the medications given in each protocol on the mother and neonates(during 48 hours following surgery)
- To compare the amount of breastfeeding between 2 groups(Following the week after surgery)
- Total amount of pain medications required in each study group(during 48 hours following surgery and after 7 days)
研究者
enav yefet
MD/PhD
HaEmek Medical Center, Israel