跳至主要内容
临床试验/NCT05837013
NCT05837013
已完成
不适用

Comparison of Open and Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TEP) Performed Under Blocked Spinal Anesthesia and General Anesthesia: Prospective Randomized Study

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 34 人2023年9月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pain, Postoperative
发起方
Konya City Hospital
入组人数
34
试验地点
1
主要终点
Postoperative pain
状态
已完成
最后更新
2年前

概览

简要总结

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the most frequently applied method is laparoscopic total extraperitoneal repair (TEP). In general, this surgery is performed under general anesthesia (GA) in many centers. However, in cases where general anesthesia is inconvenient, local or other anesthesia methods are preferred.

It has been stated in many studies in the literature that this surgery can be performed with methods other than general anesthesia. In a study of 480 patients, one of which was Sinha et al., it was shown that this surgical procedure was successfully performed under spinal anesthesia (SA).

In a prospective randomized study by Dönmez et al., patients who underwent TEP under general anesthesia and spinal anesthesia were compared. It has been reported that TEP repair can be performed safely under SA and that SA is associated with less postoperative pain, better recovery, and better patient satisfaction than GA.2 In a retrospective study by Yıldırım et al. It has been shown that there is significantly less need for analgesics and better patient satisfaction.

There are also many meta-analyses made on this subject in the literature. Compared with GA in these, SA was associated with a longer operative time, and postoperative pain and nausea and vomiting were less in SA. However, the risk of urinary retention in SA was significantly increased. It was observed that there was no significant difference in surgical complications such as seroma and wound infection.

Despite all these studies, until now, there is no clear consensus on which anesthesia should be used.

The aim of the study is to show the effect of both the surgical method and the anesthesia method on the patient during surgery and in the early postoperative period in inguinal hernia

详细描述

Patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair and open surgical procedure (Lichtenstein) with the diagnosis of inguinal hernia will be divided into 2 groups. General anesthesia (GA) will be applied to the 1st group, and ileoinguinal (II) and ileohypogastric (IH) nerve block together with spinal anesthesia (SA) to the 2nd group.

注册库
clinicaltrials.gov
开始日期
2023年9月20日
结束日期
2024年2月15日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Konya City Hospital
责任方
Principal Investigator
主要研究者

Mehmet Eşref Ulutaş

Principal Investigator

Konya City Hospital

入排标准

入选标准

  • Patients with inguinal hernias.
  • Over 18 years old

排除标准

  • Younger than 18 years
  • Those who have had previous abdominal surgery,
  • Incarcerated or strangulated inguinal hernias,
  • Recurrent hernias,
  • Coagulopathies,
  • Patients with musculoskeletal deformity,
  • Those with chronic pain,
  • Those who use drugs that affect the central nervous system daily,
  • Those with a body mass index (BMI) over 40 kg/m2,
  • Patients with contraindications to the recommended anesthetic technique.

结局指标

主要结局

Postoperative pain

时间窗: Postoperative 24 hours

It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.

次要结局

  • Adverse postoperative events(Postoperative 24 hours)

研究点 (1)

Loading locations...

相似试验