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临床试验/NCT06201546
NCT06201546已完成不适用

Comparison of Abdominal Plane Blocks in Terms of Efficiency and Complications in Postoperative Pain Control in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Fatih Sultan Mehmet Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Numeric Rate Score (NRS)

研究概览

简要总结

The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analgesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.

详细描述

After laparoscopic sleeve gastrectomy, patients have pain due to surgery. Different analgesic methods are preferred for pain relief. One of the methods used for this purpose is regional anesthesia. Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) and transversus abdominis plane (TAP) block are also plan blocks used for this purpose. TAP block is formed by injecting local anesthetic into the neurofacial space between the transversus abdominis muscle and the internal oblique muscle through the Petit triangle in the lumbar region. TAP block creates dermatomal sensory block in the lower, lower thoracic and upper lumbar abdominal afferents. It is thought that the modified thoracoabdominal plane block-perichondrial approach (M-TAPA), which is a block frequently used in upper abdomen surgeries in recent years, can provide effective analgesia in LSG surgeries. M-TAPA block is created by administering local anesthetic between the transverse abdominis muscle and the internal oblique muscle with a single injection under the costal cartilage under ultrasound guidance. With M-TAPA, analgesia can be provided in thoracic 4 and thoracic 11-12 dermatomes.

Blocking of T4-12 nerve endings may be required in LSG surgeries, since gastric innervation and thoracic inlets are located in the upper abdomen dermatomes. In studies, the use of M-TAPA block in upper abdominal surgeries may be effective in the management of analgesia in participants. In this study the investigators aimed that, compression in terms of efficiency and complications TAP and M-TAPA blocks, who is undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analjesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. After obtaining ethical committee approval (12.01.2023/1), between January 26, 2023, and May 15, 2024, 60 patients undergoing laparoscopic sleeve gastrectomy with American Society of Anesthesiologists (ASA) II-III status provide informed consent. Participants who are planing to receive M-TAPA block defines as Group M-TAPA, and those who receive TAP block defines as Group TAP, with 30 patients in each group.The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.

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
Double (Participant, Investigator)

盲法说明

Due to the double-blind nature of the study, the outcome of the effectiveness of plane blocks will not be known by the anesthesiologist and the patient until the end of the study. Only the effectiveness of blocks will be followed by an another researcher

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18-65, including the ASA I-III group, who underwent laparoscopic sleeve gastrectomy by the General Surgery clinic between January 26, 2023 and May 15, 2023

排除标准

  • Patients with coronary artery disease
  • Patients with cerebrovascular disease
  • Patients with peripheral artery disease
  • History of chronic analgesic use
  • Patients with coagulopathy
  • Patients not between the ages of 18-65
  • Patients with hepatic and/or renal insufficiency
  • Patients with missing information in the information form

结局指标

主要结局

Numeric Rate Score (NRS)

时间窗: It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

NRS is a 0 to 10 scale that describes pain from good to worst.

Visual Analog Scale (VAS)

时间窗: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

VAS is a 10-centimeter scale and is used to evaluate pain.

Pain Controlled Analgesia (PCA)

时间窗: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

PCA is includes 300mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock

次要结局

  • postoperative nausea and vomiting scale (PNV)(It will be evaluated with nause and vomiting score at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Nur Teke

MD, assistant doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (2)

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