Effectiveness of Quadratus Lumborum Block in Reducing Postoperative Pain, Enhancing Mobilization, and Shortening Hospital Stay in Children Undergoing Iliac Bone Harvest for Cleft Alveolus Repair- a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative Pain at the Donor Site at Rest, Measured by VAS
研究概览
简要总结
This prospective, randomized, double-blinded controlled trial will investigate the effectiveness of a lateral quadratus lumborum (QL) block in 50 children aged 6-14 years undergoing iliac crest bone grafting for cleft alveolus repair. Participants will receive either a lateral QL block with bupivacaine and adrenaline or a sham skin puncture.
The study will primarily assess postoperative pain at the iliac crest donor site. Secondary outcomes include pain during mobilization, pain at the alveolar surgical site, opioid consumption, time to first rescue analgesia, objective mobilization measured with activity monitors, time to hospital discharge, and adverse events.
The study aims to determine whether QL block provides clinically relevant postoperative analgesia while facilitating earlier mobilization and potentially reducing hospital stay in this pediatric population.
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with cleft lip, palate and alveolus.
- •Scheduled for iliac crest bone grafting for cleft alveolus repair.
- •ASA physical status I-II.
- •Age from 6- 14 years old.
- •Written informed consent of the patients and their legal guardians
排除标准
- •Allergy to local anaesthetics (e.g., bupivacaine)
- •Coagulation disorders or other contraindications to regional anaesthesia.
- •Neurological or developmental disorders that affect pain assessment or mobilization.
- •Skin infection at the QL injection site
- •Children and their parents who cannot speak or understand Norwegian
- •Any reason why, in the opinion of the investigators, the patient should not participate
研究组 & 干预措施
Quadratus lumborum block
干预措施: Lateral quadratus lumborum block (Procedure)
Sham treatment (skin puncture)
干预措施: Sham Block (Procedure)
结局指标
主要结局
Postoperative Pain at the Donor Site at Rest, Measured by VAS
时间窗: From 2 hours to 48 hours after the surgical procedure
次要结局
- Postoperative pain at the donor site while standing upright, Measured by VAS(12 hours and 24 hours after the surgical procedure)
- Postoperative Pain at the the recipient surgical site (alveolus), Measured by VAS(From 2 hours to 48 hours after the surgical procedure)
- Time to first analgesic request, Measured in hours(From 0 hours to 48 hours after the surgical procedure)
- Cumulative opioid consumption at 24 hours(From 0 hours to 24 hours after the surgical intervention)
- Number of steps measured with a motion monitor during the first 24 hours(From 0 hours to 24 hours after the surgical intervention)
- Time spent upright during the first 24 hours(From 0 hours to 24 hours after the surgical intervention)
- The time (in hours) from surgery to discharge from the hospital(From 0 hours after the surgical procedure until discharge from hospital)
- Side effects and adverse events(From Anaesthesia induction until 48 hours after the surgical procedure)
研究者
Axel Rudolf Sauter
MD PhD
Oslo University Hospital