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临床试验/NCT05592496
NCT05592496进行中(未招募)不适用

Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.

Riga East Clinical University Hospital4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
4
主要终点
Pain scores

研究概览

简要总结

In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.

详细描述

This prospective randomised case-control experimental study is being conducted in Riga East University Hospital (Latvia). Patients with total or subtotal open gastrectomy were divided into two groups - half patients in the Block group and half patients in the Control group. In the Block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. Catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision.

After surgery patients in the Block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. Additionaly ketorolac or trimeperidine infusion will be performed if VAS of pains more than 30mm. If pains continue, additional opioids will be performed.

Patients in the Control group received 0,9% NaCl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery Pain intensity will be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Open Laparotomy and gastrectomy

排除标准

  • acute surgery

结局指标

主要结局

Pain scores

时间窗: 3 days

Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery

Opioid usage after surgery

时间窗: 3 days

If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed

次要结局

  • Postoperative complications(approximately 14 days)
  • Time to discharge(approximately 7 days)
  • Peri-operative analgesic use(4 days)
  • TIme to diet and mobilisation(likely 5 days)

研究者

发起方
Riga East Clinical University Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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