Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in total QoR-15 score
研究概览
简要总结
Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.
详细描述
Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.
In this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.
After signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.
The main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
- •Have given an informed written consent
- •Able to read and understand french language
- •Affiliation to a social security system
排除标准
- •Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),
- •Epidural analgesia contraindication
- •With impossibility to set up bilateral rectus sheath block
- •Participation in another clinical study
- •Pregnant women
- •Patients deprived of their liberty by a judicial or administrative decision,
- •Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
研究组 & 干预措施
Thoracic epidural anesthesia
Epidural analgesia during midline laparotomy
干预措施: Laparotomy (Procedure)
Thoracic epidural anesthesia
Epidural analgesia during midline laparotomy
干预措施: Epidural analgesia (Drug)
Bilateral rectus sheath block
Bilateral rectus sheath block during midline laparotomy
干预措施: Bilateral rectus sheath block (Drug)
Bilateral rectus sheath block
Bilateral rectus sheath block during midline laparotomy
干预措施: Laparotomy (Procedure)
结局指标
主要结局
Change in total QoR-15 score
时间窗: Postoperative day 2
The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).
次要结局
- Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery(Postoperative days 1, and 3)
- Efficacy of postoperative analgesia(Day 0 and Postoperative days 1, 2, 3 and 30)
- Impact of arterial hypotension(Postoperative days 1, 2 and 3)
- Impact of orthostatic hypotension(Postoperative days 1, 2 and 3)
- Occurrence of nausea and/or vomiting(Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days)
- Postoperative complications link to analgesic technique(Postoperative days 1, 2 and 3)
- The length of stay(at hospital discharge up to 30 days)
- Return to normal bowel function(Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days)
- The quantity of morphine or equivalent(Day 0 and Postoperative days 1, 2 and 3)
- Urinary catheterization(at hospital discharge up to 30 days)
- Total distance covered(Postoperative days 1, 2 and 3)
- Failure to set up a catheter(Postoperative day 1)
- The time until the first raised(Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days)
- Impact of premature discontinuation of local anesthetic perfusion(on day 0)
- Patient satisfaction and need for further consultation(at hospital discharge up to 30 days and on postoperative day 30)