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临床试验/NCT06242028
NCT06242028已完成不适用

Use of Dexamethasone Via Two Different Methods in PENG Block for Patients Undergoing Femoral Fracture Surgery

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Pain scores on the Numeric Rating Scale (NRS)

研究概览

简要总结

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied investigation of the effect of perinuerally and systemic dexamethasone on pain scores in the first 24 hours of PENG block in patients undergoing hip fracture surgery under spinal anesthesia.

详细描述

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied investigation of the effect of perinuerally and systemic dexamethasone on pain scores in the first 24 hours of PENG block in patients undergoing hip fracture surgery under spinal anesthesia.

44 ASA II-IV patients between 50-80 years of age who will be operated for femoral neck fractures will be included in the study.

PENG block is routinely used in our clinic to provide postoperative analgesia in hip surgery. Depending on the comorbid conditions of the patients, dexamethasone may be added as an adjuvant agent to improve the quality of the block. We aimed to observe the systemic and perinuerally effects of dexamethasone used in PENG block in patients operated for femoral neck fracture in our clinic.

In this observational and prospective study, patients operated for femoral neck fracture and treated with PENG block will be analyzed in the postoperative period. Pain scores, degree of nausea and vomiting, recovery time of sensory and motor block, and blood glucose levels in the first 24 hours will be recorded in patients who received dexamethasone perinuerally and in patients who received systemic dexamethasone intravenously. In addition, the time to first analgesic requirement, mobilization time and hospital stay of the two groups will also be recorded.

The anesthesiologist performing the block will not participate in the pain monitoring of the patients. Postoperative pain assessment and data collection will be performed by another anesthesiologist blinded to the study. For the quality and standardization of the block, the block will be performed by an experienced anesthesiologist who has performed the block successfully and without complications at least 20 times before.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-85 years old
  • Patients who underwent surgery for femoral neck fracture under spinal anesthesia with PENG block
  • Patients of either sex with a body mass index (BMI) < 35 kg/m2
  • ASA II-IV patients
  • Patients signing the informed consent form

排除标准

  • ASA-V patients
  • Alcohol, drug addiction
  • Patients with a history of opioid drug use for more than four weeks
  • Patients with chronic pain disorders (patients on regular analgesics >3 months)
  • Patients with a history of local anesthetic or opioid allergy or hypersensitivity
  • Patient group in whom regional anesthesia is contraindicated (coagulopathy, INR (international correction ratio) not within normal limits, thrombocytopenia or platelet dysfunction, infection at the injection site)
  • Those with severe psychiatric illnesses such as psychosis, dementia, etc. that limit their cooperation with the patient
  • Patients who do not give consent/ do not want to participate
  • Patients who were evaluated as failed block on dermatomal examination after block application

研究组 & 干预措施

Group P (Perinuerally)

Ultrasound guided PENG block with perinuerally dexamethasone administration group

干预措施: Group P (Drug)

Group S (Systematic)

Ultrasound guided PENG block with systemic dexamethasone administration group

干预措施: Group S (Drug)

结局指标

主要结局

Pain scores on the Numeric Rating Scale (NRS)

时间窗: Postoperative 0th, 6th,12th and 24th hours

Changes in Numeric Rating Scale (NRS) at rest and in activity will be recorded at intervals. At 0-6-12-24 hours, pain will be evaluated with the NRS score in two different situations. Patients will be informed about the Numeric Rating Scale used in the assessment of pain and pain intensity will be determined at rest and 24 hours postoperatively during 15 degrees passive leg raising. Patients will be asked to express their pain intensity numerically between 0 and 10, with 0 for no pain and 10 for the most severe pain.

次要结局

  • Postoperative nausea and vomiting(Postoperative 6th, 12th and 24th hours)
  • The degree of motor block(Postoperative 6th, 12th and 24th hours)
  • The degree of sensory block(Postoperative 6th, 12th and 24th hours)

研究者

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

Ebru Kelsaka

Professor Doctor

Ondokuz Mayıs University

研究点 (1)

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