Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The onset of motor blockade
研究概览
简要总结
Patients were randomly allocated into Two equal study groups each contain (40) patients : Patients in Group A received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline and patients in Group B received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg).
The investigators found that neostigmine when used as an adjuvant to bupivacaine in ultrasound guided supraclavicular brachial plexus block has advantage over bupivacaine alone especially in the quality of sensory block and provide safe and effective post-operative analgesia in patients undergoing forearm surgeries
详细描述
All patients were assessed with regards to:
Hemodynamics (heart rate, Bp) and oxygen saturation were recorded preoperatively just before the block as a baseline value, immediately after the block 5, 20, 30,40,45 , 60 minutes during the operative time and 1, 2, 4, 6, 9 and 12 hours after end of operation.
Onset time of sensory block, Onset time of motor block, Duration of sensory block, and Duration of motor block.
Pain assessment using a scoring system based on the visual analogue pain scale(VAS) measured at the following time intervals 0, 2, 4, 6, 9, 12 and 24 post operatively, time to first analgesic requirement (in hours) and total analgesic consumption was monitored in the two groups for 24 hours in ward.
The incidence of adverse effects whether related to the drugs used in the technique or related to the technique itself were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA ( I-II)
- •Age: from ≥18 years
- •Sex: male or female
- •type of operation : Forearm Orthopedic surgeries
- •Type of anaesthesia : supraclavicular brachial plexus block
- •Duration of operation : 60-90 min
排除标准
- •Patient refusal for the procedure
- •Any bleeding tendency
- •Neurological deficits involving brachial plexus
- •Patients with allergy to local anesthetics
- •Local infection at the site of injection
- •Patients on any sedatives or antipsychotics
- •Body mass index >35.
研究组 & 干预措施
Control group
This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline
干预措施: ultrasound- guided supraclavicular brachial plexus block (Procedure)
Neostigmine group
This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg)
干预措施: ultrasound- guided supraclavicular brachial plexus block (Procedure)
结局指标
主要结局
The onset of motor blockade
时间窗: Every 2 minutes for 30 minutes
Onset time for motor block was defined as the time interval between the end of local anesthetic administration until complete motor block by minutes
Duration of sensory blockade
时间窗: Every 1 hour for 24 hours
Duration of sensory block was defined as the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves by hours
Duration of motor blockade
时间窗: Every 1 hour for 24 hours
the time interval from complete motor block to complete recovery of motor function of hand and forearm by hours
The onset of sensory blockade
时间窗: Every 2 minutes for 30 minutes
Onset time for sensory block was defined as the time interval between the end of local anesthetic administration untill complete sensory block by minutes
次要结局
- Duration of analgesia (first request for analgesic)(Every 30 minutes for 4 hours then every 2 hours for 24 hours)
- Visual analogue pain score(2,4,6,8,12,16,20 and 24 hours postoperative)
研究者
ABEER HASSANIN
Assistant Professor
Minia University