Comparing Quadratus Lumborum Type 1 Block to The Combination Of Intraperitoneal Instillation Of Local Anesthetics And Wound Infiltration For Postoperative Pain After Cesarean Delivery: A Prospective Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- difference between total opioid consumption in 24 hours
研究概览
简要总结
This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.
详细描述
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged between 18 to 50
- •American Society of Anesthesiologists (ASA) II classification,
- •full-term and singleton pregnancies planned to undergo cesarean section
- •using Pfannenstiel incision
- •spinal anaesthesia
排除标准
- •whom neuraxial anaesthesia is contraindicated,
- •those who are allergic to drugs to be used in the study,
- •who refused to participate in the study,
- •those with BMI>35 kg/m2,
- •ASA score ≥3 or higher,
- •diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain,
- •individuals who have received opioids during the surgical procedure for intraoperative pain,
- •patients who have undergone abdominal surgery,
- •patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure,
- •those with excessive bleeding during the operation,
- •who have uterine atony,
- •those who have a drain placed in the area to be infiltrated,
- •those who cannot understand the Visual Analog Scale (VAS),
- •who have a history of drug addiction and psychiatric disorder
结局指标
主要结局
difference between total opioid consumption in 24 hours
时间窗: postoperative 24 hours
The study will involve monitoring the intake of opioids at specific time intervals (2nd, 4th, 6th, 12th, and 24th hours), calculating the cumulative opioid consumption until the 24th hour
次要结局
未报告次要终点
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University