Nalbuphine Versus Midazolam as an Adjuvant to Intrathecal Bupivacaine for Postoperative Analgesia in Patients Undergoing Cesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total postoperative analgesic dose .
研究概览
简要总结
Adequate pain management is important to facilitate the functional recovery and enable the patients for rapid rehabilitation of normal activity .
Various adjuvants were being used with intrathecal bupivacain to prolong & improve postoperative pain relief in patients undergoing cesarean section .
The aim of this study was to compare intrathecal nalbuphine versus intrathecal midazolam in patient undergoing cesarean section. The investigators primary aims were to compare the characteristics of sensory and motor block, the effective analgesic time, and analgesic requirement. Secondary aims were to compare the side effects, sedation score and apgare score.
详细描述
Analgesia is the main point for each patient postoperatively. It is important to provide good analgesia with less hazardous (1). Cesarean section is a painful operation in need for adequate postoperative analgesia (1). Adequate pain management is important to facilitate the functional recovery and enable the patients for rapid rehabilitation of their normal activity (2).
Cesarean section was done under general anesthesia (GA) or regional anesthesia. The subarachnoid blockade is the preferred procedure (3). It avoids the depressant effect of GA on neonate and also the risk of aspiration, with better postoperative pain relief. However the most commonly local anesthetic used, hyperbaric bupivacaine has limited effect lasts for 1.5 - 2 hours (4). Its onset was slow with short duration of postoperative analgesia (3).
Adjuvant drugs added to bupivacaine intrathecally improve the duration and quality of the blockade and prolong the postoperative analgesia (5). Various adjuvants were being used such as alpha2 agonists, neostigmine, opiates, and ketamine etc, yet no drug was identified to specifically inhibit nociception without side effects (6).
Nalbuphine is a synthetic opioid with mixed agonist antagonist effect. It provides a significantly rapid onset of pain relief probably because of its lipophilic properties. It binds to both mu-and kappa receptors, binding of nalbuphine to mu receptors competitively displace other mu-agonists from these receptors without any agonist activity. Therefore decrease the side effects of mu agonist (nausea, vomiting, respiratory depression , urinary retention, pruritis and prolonged sedation) (7). While when binds to kappa receptors nalbuphine has agonist effect (analgesic effect) through the kappa receptors distributed in the brain and spinal cord(1). There were no documented studies of nalbuphine neurotoxicity (5, 8).
Benzodiazepines are used mainly for sedation, anoxiolysis and amnesia. Discovery of their receptors in spinal cord allow the use of midazolam intrathecally for analgesia. Several studies show that the addition of intrathecal midazolam potentiates the analgesic effect of intrathecal bupivacain without significant side effects, or neurotoxicity (9, 10).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender .
- •Age : 18 - 40 years old .
- •Physical status : ASA II .
- •Elective cesarean section
排除标准
- •- Patient refusal .
- •History of hypertension or cardiac diseases .
- •Psychiatric disorders .
- •Coagulopathy .
- •Allergy to study drugs .
- •Contraindication to spinal anesthesia .
- •Failure of spinal anesthesia .
研究组 & 干预措施
nalbuphine
12.5 mg hyperbaric bupivacaine + 1 mg nalbuphine add in 0.5 ml 0.9% normal saline.
干预措施: Nalbuphine (Drug)
bupivacaine
12.5 mg hyperbaric bupivacaine + 0.5 ml 0.9% normal saline .
干预措施: Bupivacaine (Drug)
midazolam
12.5 mg hyperbaric bupivacaine + 2.5 mg midazolam .
干预措施: Midazolam (Drug)
结局指标
主要结局
Total postoperative analgesic dose .
时间窗: 24 hours
the analgesic dose consumed
Effective analgesic time
时间窗: up to six hours postoperative
the time start from intrathecal injection to the first analgesic dose.
Onset of sensory and motor block
时间窗: up tp five minutes after intrathecal injection
the time of onset of sensory and motor block
duration of sensory and motor block
时间窗: up to five hours postoperative
the time of duration of sensory and motor block
次要结局
- Sedation score(one hour during surgery)
- Apgar score(1-5 minutes after delivery)
- number of participants with hypotension , bradycardia ,vomiting , nausea , shivering number of participants with hypotension , bradycardia ,vomiting , nausea , shivering(up to 24 hours postoperative)
研究者
olfat abd elmoniem ibrahem
principal investigator
Zagazig University
