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临床试验/NCT06595875
NCT06595875已完成不适用

Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Controlled, Double-Blind Study

Konya City Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月7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
60
试验地点
2
主要终点
Postoperative analgesia

研究概览

简要总结

Our primary objective is to evaluate the postoperative numerical rating scale scores in patients undergoing laparoscopic cholecystectomy with an m-TAPA block. Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and the occurrence of complications.

详细描述

Patients aged 18-65 with American Society of Anesthesiologists physical status I-III, undergoing laparoscopic cholecystectomy under general anesthesia, were included in the study. Patients with contraindications to regional anesthesia, impaired consciousness, coagulopathy, those using anticoagulants, those with infection at the procedure site, those with allergies to local anesthetics, pregnant women, and emergency cases were excluded from the study.

The primary outcome measures were the numerical rating scale pain scores (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain) at 0, 2, 4, 8, 12, and 24 hours postoperatively. The secondary outcome measures included the total amount of rescue analgesic consumed, the time to first rescue analgesia, the occurrence of complications (such as infection, hematoma formation, and local anesthetic systemic toxicity), and patient satisfaction. The age, gender, weight, height, surgery duration of patients in both groups were recorded. A Likert scale (1 = not satisfied at all, 2 = not satisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) was used to assess patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

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

  • 18-65 years
  • American Society of Anesthesiologists physical status I-III
  • Laparoscopic cholecystectomy under general anesthesia

排除标准

  • Patients with contraindications to regional anesthesia
  • Impaired consciousness
  • Coagulopathy
  • Using anticoagulants
  • Infection at the procedure site
  • Allergies to local anesthetics
  • Pregnant women
  • Emergency cases

结局指标

主要结局

Postoperative analgesia

时间窗: 24 hours

Our primary objective is to evaluate the postoperative numerical rating scale scores in patients undergoing laparoscopic cholecystectomy with an m-TAPA block. Numerical rating scale score 0-10 point. 0= Very bad, 10= Vey Good.

次要结局

未报告次要终点

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Halit Satici

Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D

Konya City Hospital

研究点 (2)

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