NCT06002217已完成不适用
Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.
Clinique Saint Jean, France2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月5日最近更新:
适应症
干预措施
相关药物
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
- 2
- 主要终点
- Analgesic consumption
研究概览
简要总结
The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery.
The main question it aims to answer :
• whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days.
Researchers will compare tap block vs placebo to see if it reduces postoperative pain.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patient affiliated or entitled to a social security plan.
- •Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.
- •Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.
- •Patient with ASA criteria 1, 2 and 3.
排除标准
- •Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.
- •Patients allergic to local anesthetics.
- •Pregnant or breast-feeding patient.
- •patient undergoing cancer or trauma surgery trauma.
- •Patient participating in another interventional study.
- •Patient with a history of lumbar arthrodesis.
- •Patient refusing to sign consent form.
- •Patient unable to give informed consent.
- •Patient under court protection, guardianship or trusteeship.
- •Patient not available for study follow-up.
研究组 & 干预措施
TAP Block
Active Comparator
干预措施: Levobupivacaine (Drug)
saline solution
Placebo Comparator
干预措施: Placebo Tap block (Other)
结局指标
主要结局
Analgesic consumption
时间窗: 72hours
The use of analgesics (oral or venous) during the during the 72 hours following surgery
次要结局
- Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10(72hours)
研究者
Guillaume LONJON
Principal investigator
Clinique Saint Jean, France
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Ultrasound-guided Transversus Abdominis Plane Block Versus Local Wound Infiltration (TAP_WI)Transversus Abdominis Plane (TAP) BlockWound InfiltrationPain Score (VAS)Opioid AnalgesiaNCT06627946Ministry of Health, Bhutan100
终止
不适用
Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic ColectomyLaparoscopic Colorectal ResectionNCT02164929Duke University17
已完成
不适用
TAP vs. ESP Block for Gynecological Post Operative PainNerve BlockPain, PostoperativeNCT06044779Universitas Padjadjaran40
终止
4 期
Transversus Abdominis Plane Block After Robot-assisted Laparocopic HysterectomyHysterectomyNCT01504386Copenhagen University Hospital at Herlev70
已完成
4 期
Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon SurgeryLaparoscopic Colon SurgeryNCT01418144Copenhagen University Hospital at Herlev80