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临床试验/NCT06384677
NCT06384677已完成不适用

Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

Marmara University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

详细描述

The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patient > 17 years old
  • •ASA score 1-3
  • •undergoing major intra-abdominal surgery

排除标准

  • •ASA IV patients
  • •patients with known neurological or psychiatric disorders
  • •patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
  • •patients with long-term drug (opioid) or alcohol dependence
  • •patients with BMI>30
  • •patients with intellectual disability
  • •patients who developed massive bleeding and coagulopathy

研究组 & 干预措施

M-Tapa + IV PCA applied group

Other

After appropriate skin disinfection, the transversus abdominis, internal oblique and external oblique muscles were determined with a high-frequency linear probe (Esaote) at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal border. A 21-G, 80-mm peripheral block needle was placed in the cranial direction using the in-plane technique, the needle tip did not exceed the cranial edge of the 10th costal cartilage, and 20 ml of 0.25% bupivacaine was applied to the lower surface of the chondrium on both sides, right and left. .

干预措施: M-Tapa Block (Other)

IV PCA applied group

Other

In the IV PCA group, the surgeon performed local infiltration with 40 mL of 0.25% bupivacaine around the incisions. All patients were provided postoperative analgesia with intravenous patient-controlled analgesia (IVHKA). When pain was expressed by the patient, the patient pressed a button and the IV HKA pump was programmed to deliver a 1 ml bolus dose with a 10-minute lockout interval and no background infusion allowed. Each 1 ml of IVHKA solution contains 1 mg of morphine.

干预措施: M-Tapa Block (Other)

结局指标

主要结局

Opioid Consumption

时间窗: Postoperative 24 hours

The postoperative opioid consumption

次要结局

  • the need for rescue analgesia(postoperative 24 hours)
  • side effects(postoperative 24 hours)
  • NRS Scores(postoperative 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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