The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Sensory and motor block
研究概览
简要总结
The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.
详细描述
The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiology physical status I-II patients
- •aged 18-65 years
- •undergoing elective unilateral open inguinal hernia repair surgery
排除标准
- •contraindications to spinal anesthesia
- •central or peripheral neuropathies
- •severe respiratory or cardiac diseases
- •chronic analgesic use
- •history of substance abuse
- •allergy to local anesthetics
研究组 & 干预措施
intrathecal morphine 0.1 mg
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine
干预措施: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg (Drug)
intrathecal morphine 0.1 mg
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine
干预措施: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland (Device)
intrathecal morphine 0.1 mg
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine
干预措施: intravenous cannulation and premedication (Drug)
0.4 mg of intrathecal morphine
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine.
干预措施: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg (Drug)
0.4 mg of intrathecal morphine
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine.
干预措施: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland (Device)
0.4 mg of intrathecal morphine
After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine.
干预措施: intravenous cannulation and premedication (Drug)
结局指标
主要结局
Sensory and motor block
时间窗: The change in motor block and sensory block levels will be assessed after performing spinal block, every 5 minutes for 30 minutes and then at the end of the procedure.
Sensory and motor block produced by the spinal anaesthesia will be assessed prior the procedure to define readiness for surgery and then once the procedure is over, sensory and motor block levels will be assessed one more time to follow up the block regression times. Motor block will be assessed with Bromage scale (0: no motor block, 1: hip blocked; 2: hip and knee blocked; 3: hip, knee and ankle blocked). Sensory block will be assessed using loss of pinprick sensation. The onset of surgical anesthesia is defined as loss of pinprick sensation at ≥ T10 with a Bromage score ≥ 2.
次要结局
- first mobilisation, first urination and first analgesic times(after the procedure, during the first 24 hours)
研究者
Basak Ceyda MECO
MD, DESA
Ankara University