Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
研究概览
简要总结
The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.
详细描述
In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.
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
- 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
- 是
入选标准
- •IInclusion criteria
- •Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area
- •Patients able to provide informed written consent
- •Patients capable of completing questionnaires at the time of consent
排除标准
- •Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone
- •Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)
- •Urgent or emergent surgery precluding epidural catheter placement or TAP block
- •Systemic Infection contraindicating epidural catheter placement or TAP block
- •Rectal surgery
- •Pregnant or suspected pregnancy
- •Age < 18 years
- •Planned open surgery
- •Planned bowel stoma (protective diversion and/or permanent stoma)
- •Unwillingness to participate in follow-up assessments
- •Patients with severe chronic pain
- •Known sensibility for opioid side effects
- •i.v.-PCA is contraindicated (for example drug abuse)
- •No informed consent
研究组 & 干预措施
TAP block group
Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery
干预措施: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia (Other)
Epidural analgesia group
Patients undergo epidural catheters placement for laparoscopic colorectal surgery
干预措施: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia (Other)
结局指标
主要结局
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
时间窗: Up to 1 month
The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery
次要结局
- Time to first flatus(Up to 1 month)
- Overall benefit of analgesia score (OBAS)(Up to 1 month)
- Overall operating theatre time(Up to 10 hours)
- Post-operative morphine milligram equivalents recruitments(Up to 1 month)
- Time to post-operative mobilization(Up to 1 month)
- Visual analogue scale(Up to 1 month)
- Hospital readmission(30 and 90-day)
- Overall cost-effectiveness(Up to 6 months)
- Time to first bowel movement(Up to 1 month)
- Post-operative complications related to interventions according to Clavien-Dindo classification(30 and 90-day)
研究者
Heikki Huhta
Gastointestinal Surgeon, Adjunct Professor
Oulu University Hospital