The Incidence of Post-Operative Lung Atelectasis With Erector Spinae Plane Block in Bariatric Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Lung atelectasis
研究概览
简要总结
We aim to compare the incidence of post-operative lung atelectasis with erector spinae plane block versus systemic analgesia in patients undergoing bariatric surgery
详细描述
Patients will be randomly allocated at a 1:1 ratio into two groups, using a computer-generated random sequence and concealed envelopes that contained group assignments and drug preparation instructions.
Group I (control group): Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side.
Group II (ESPB group): Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.
An experienced anesthetist will open the envelopes, prepare the local anesthetics, and perform the assigned technique with no further involvement in the study.
A blinded investigator (an anesthesia and pain therapy specialist) will be responsible for perioperative data collection, pain assessment during the first 24 postoperative hours, and providing analgesia. All patients were blinded to the assigned technique.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
An experienced anesthetist will open the envelopes, prepare the local anesthetics, and perform the assigned technique with no further involvement in the study.
A blinded investigator (an anesthesia and pain therapy specialist) will be responsible for perioperative data collection, pain assessment during the first 24 postoperative hours, and providing analgesia. All patients were blinded to the assigned technique.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with body mass index ≥35 kg/m2
- •scheduled to undergo laparoscopic bariatric surgery.
排除标准
- •American Society of Anesthesiologists (ASA) physical class> III.
- •Subjects with contraindications to peripheral regional anesthesia blocks
- •neurological or psychological disorders
- •inability to cooperate
- •pre-existing chronic pain or cognitive dysfunction
研究组 & 干预措施
control group
Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side.
干预措施: ESPB (Drug)
ESPB group
Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.
干预措施: ESPB (Drug)
结局指标
主要结局
Lung atelectasis
时间窗: 6 hours
Lung atelectasis (defined as lung ultrasound score ≥2 in any lung region)
次要结局
- NRS(24 hours)
研究者
Khaled Abdelfattah Abdallah Sarhan
principal investigator, Asst. professor of anesthesia, Cairo university
Kasr El Aini Hospital