跳至主要内容
临床试验/NCT05847842
NCT05847842Enrolling By Invitation不适用

Comparison of the Effects of Local Anesthetic Infiltration and Different Fascial Plane Blocks on Postoperative Recovery Quality and Pain in Inguinal Hernia Repair

Eskisehir Osmangazi University4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
4
主要终点
Quality of recovery assessed by Quality of recovery scale (QoR-15)

研究概览

简要总结

In this study, quadratus lumborum block (QLB), transversus abdominis plane (TAP) block, and local anesthetic infiltration will be performed preoperatively in patients who will undergo unilateral inguinal herniorrhaphy operation under general anesthesia. Quality of recovery (QoR-15) score, postoperative acute and chronic pain levels will be evaluated.

详细描述

Inguinal hernia repair, one of the most common operations, causes moderate to severe postoperative pain. The postoperative pain delays patients' recovery and return to daily life, increases the rate of readmission to the hospital, and can lead to persistent postoperative pain.Procedure-specific postoperative pain management (PROSPECT) recommendations for optimal pain management have been recently updated. Accordingly, in addition to preoperative or intraoperative paracetamol and nonsteroidal anti-inflammatory analgesics, local anesthetic infiltration and/or regional analgesia techniques (ilio-inguinal nerve blocks or TAP block) with rescue opioids are recommended. Also, it has been reported that further research is needed on new regional techniques (other fascial plane blocks etc).It has been shown that QLB potentially results in extensive sensory blockade (T7-12), and in cadaver studies, the iliohypogastric and ilioinguinal nerves are constantly involved. In addition, there are studies suggesting that it provides much longer analgesia than TAP block. There are few studies on its efficacy in inguinal hernia repair that are in pediatric cases or performed in addition to central blocks. It is hypothesized that QLB may provide better and longer analgesia, may increase the quality of recovery and reduce the development of resistant chronic pain, compared to other regional methods such as local infiltration or TAP block, that proven effectiveness.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
  • American Society of Anesthesiology (ASA) physical classification I-III

排除标准

  • Patients who will undergo laparoscopic surgery
  • Previous inguinal hernia repair surgery
  • A history of opioid use or pain management
  • Coagulopathy or anticoagulant use
  • Patients who have difficulty communicating or who are not cooperative

结局指标

主要结局

Quality of recovery assessed by Quality of recovery scale (QoR-15)

时间窗: Postoperative 24th hour.

The 15-item quality of recovery (QoR-15) scale is a questionnaire used to evaluate the postoperative recovery quality of patients in the early postoperative stages. The QoR-15 score comprises 15 questions that assess 5 recovery domains, namely, physical comfort, physical independence, psychological support, emotional status, and pain. Each question is scored from 0 to 10 (0 none of the time to 10 all of the time).

次要结局

  • Postoperative pain assessed by Numerical Rating Scale (NRS)(At the 2nd, 6th, 12th, 24th and 36th hours)
  • Postoperative chronic pain assessed by Numerical Rating Scale (NRS)(Three months later the operation date)
  • Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.(Three months later the operation date)

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulay ERDOGAN KAYHAN

Professor Doctor

Eskisehir Osmangazi University

研究点 (4)

Loading locations...

相似试验