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临床试验/NCT06183541
NCT06183541招募中不适用

Effects of Pericapsular Nerve Group (PENG) Block Applied for Analgesia on the Postoperative Process in Patients Undergoing Hip Fracture Surgery.

Umraniye Education and Research Hospital4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
4
主要终点
postoperative pain score

研究概览

简要总结

In this study, it was aimed to compare the multimodal analgesia application or the pericapsular nerve group (PENG) block methods in patients undergoing hip surgery. The effectiveness and benefit rate of the PENG block in postoperative pain will be evaluated.

Postoperative pain, need for additional analgesia, range of motion of the hip joint, mobilization time, length of hospital time and adverse events in patients undergoing hip fracture surgery with and without PENG block will be investigated.

详细描述

This prospective randomised controlled study included a total of 70 patients aged 30-85 years who underwent hip fracture surgery under spinal anaesthesia. Patients were randomly divided into two groups using the sealed envelope method, Group I: those who received PENG block (n:35) and Group II:Those who did not receive PENG block (control group) (n: 35).

All patients will undergo hip fracture surgery by the same surgical team. Each patient will be informed about the procedure to be performed during anesthesia and surgery, and signed informed consent will be obtained before the procedure.Patients in Group I who will undergo the PENG block method; Before surgery, after spinal anesthesia, PENG block is performed under sterile conditions under ultrasonography guidance. With the patient supine, a 2-5 MHz, low-frequency, curvilinear probe is placed in the transverse plane medial to the anterior inferior iliac spine (AIIS), with the medial end of the probe rotated approximately 45° counterclockwise to align with the superior pubic ramus.

With the PENG block, an 80 mm block needle is placed in the fascial plane between the psoas tendon and the pubic ramus and 20 ml of 0.5% bupivacaine is administered.

As for the patients in Group II (control group); It is a routine practice at the end of surgery; 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical area by the surgical team.

For routine postoperative multimodal analgesia, intravenous PCA (patient controlled analgesia) was administered to patients in both groups with tramadol 50 mg at a basal rate of 10 mg / hour after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv. (Given every 8 hours)

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
Single (Participant)

盲法说明

Patients who underwent PENG block and those who did not undergo PENG block are randomly divided into two groups using the sealed envelope method. They are grouped as Group I: Those who received PENG block (n: 35) and Group II: Those who did not receive PENG block (control group) (n: 35).

入排标准

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

入选标准

  • Patients who will undergo hip fracture surgery Women and men aged 30-85

排除标准

  • Patients under 30 years old, over 85 years old
  • American Society of Anesthesiology (ASA) IV,
  • Those with cognitive impairment (alzheimer, dementia, delirium, etc.)
  • Those with application site infection
  • Those who are allergic to local anesthetic substances
  • Patients are non-consenting patients.

结局指标

主要结局

postoperative pain score

时间窗: 30 min, 12th, 24th and 48th hours in the postoperative period

VAS pain score

Total opioid consumption

时间窗: postoperative 48 hours

Tramadol (mg)

mobilisation time

时间窗: postoperative 24-48 hours

take 5 steps with walker

次要结局

  • PENG block adverse events(between the time surgery starts and the 48th hour)
  • length of hospital stay(between the time of hospitalization for the operation and discharge (day))

研究者

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

Zeliha Alicikus

Assistant professor

Umraniye Education and Research Hospital

研究点 (4)

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