跳至主要内容
临床试验/NCT05344105
NCT05344105已完成不适用

Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block

Samsun Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月5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
80
试验地点
2
主要终点
Opioid use

研究概览

简要总结

The subject of the study is to compare the analgesic efficacy of transversalis fascia plan block and erector spina plane block applied with ultrasonography in patients who have undergone inguinal hernia operation. The aim of the study is to compare two different regional anesthesia methods applied in the postoperative period in terms of 24-hour opioid consumption, pain scores, additional analgesic need, and side effects and complications in the postoperative period.

详细描述

An identification number (ID) number will be randomly assigned to each patient, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, patients will be followed up with these numbers in patient follow-up. Which group the patients will be included in will be determined by the closed envelope method.

The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.

Spinal anesthesia will be applied to all patients and inguinal hernia operation will be appropriate. Patients taken to the recovery room will be divided into two groups. Transversalis fascia plan block (Group T) will be applied to the patients in a group after local cleansing of the skin area, accompanied by ultrasonography. The patients in the other group will be treated with an erector spina plane block (Group E) following local cleansing of the skin area, accompanied by ultrasonography.

In both block management, 0.25% bupivacaine (Buvasin Vem İlaç, Turkey) (15 ml physiological saline + 15 ml 0.5% bupivacaine) total amount of 30 ml, same volume and same concentration will be used.

After the block procedure, the patient will be observed in the recovery room for side effects. Patient-controlled analgesia (PCA) will be used as a standard in the treatment of postoperative pain in patients in both groups without any complications. Tramadol HCL, which is routinely used for postoperative pain control for PCA, will be used (3 mg/ml, total volume 100 mL).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.

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

  • Those who underwent unilateral inguinal hernia surgery under elective conditions
  • 18-65 years
  • ASA I-III
  • Patients with written consent who agreed to participate in the study

排除标准

  • Body mass index > 35 kg/m²,
  • Coagulopathy and local infection or hematoma in the area to be blocked,
  • Allergic to a local anesthetic agent or one of the drugs used in the study,
  • Those with a history of chronic opioid and corticosteroid use,
  • Unable to use the patient-controlled analgesia system,
  • Those with psychiatric illness,
  • Cases with a surgical time of less than 30 minutes and more than 120 minutes for better standardization of studies,
  • Patients who do not agree to participate in the study will not be included in the study.

结局指标

主要结局

Opioid use

时间窗: Postoperative 24 hours

To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.

次要结局

  • Numerical Rating Scale(Postoperative 24 hours)

研究者

发起方
Samsun Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hale Kefeli Celik

Principal Investigator, Anesthesiologist

Samsun Education and Research Hospital

研究点 (2)

Loading locations...

相似试验