Evaluation of Postoperative Analgesic Effects of Infraorbital Nerve Block by Levobupivacaine vs Ropivacaine After Cleft Palate Surgery: A Double-blinded Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days.
研究概览
简要总结
Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids.
Hence, regional block, using local anesthetics, becomes a good option in this surgery.
The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain.
Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries
详细描述
When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children in the age of 2-12 years
- •Children undergoing elective surgery for cleft palate.
- •Children who are conscious and willing to participate in the study.
- •Children who speak and understand English, Hindi, local or others.
排除标准
- •Patient's refusal
- •Allergy to the amide group of local anaesthetic agent
- •Patient on anticoagulants or bleeding disorder
- •Underlying other significant systemic diseases.
研究组 & 干预措施
Group L
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L)
干预措施: INFRA ORBITAL BLOCK (Drug)
Group R
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R).
干预措施: INFRA ORBITAL BLOCK (Drug)
结局指标
主要结局
change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days.
时间窗: Till the second post operative day.
Pain is measured using verbal rating scale
次要结局
未报告次要终点
研究者
ADABALA VIJAY BABU
Principal Investigator
All India Institute of Medical Sciences, Rishikesh