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临床试验/NCT07534137
NCT07534137已完成不适用

Comparison of Postoperative Tramadol Consumption, Clinical Effects, and Side Effects in Patients With and Without PENG (Pericapsular Nerve Group) Block in Partial Hip Prosthesis Surgery

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Total Tramadol Consumption Within 24 Hours After Surgery

研究概览

简要总结

This study aims to evaluate the effect of ultrasound-guided pericapsular nerve group (PENG) block on postoperative tramadol consumption, pain scores, and clinical outcomes in patients undergoing partial hip prosthesis surgery. Patients aged 18-75 years scheduled for surgery under general anesthesia were divided into two groups: those receiving PENG block and those not receiving the block. Postoperative tramadol consumption within the first 24 hours, visual analog scale (VAS) and numeric rating scale (NRS) scores, hemodynamic parameters, additional analgesic requirements, and recovery characteristics were recorded and compared between groups. The findings of this study are expected to contribute to optimizing multimodal analgesia strategies in hip surgery.

详细描述

Postoperative pain management in hip surgery remains a significant clinical challenge, particularly in elderly patients. Effective analgesia is essential to reduce opioid consumption, improve patient comfort, and enhance recovery. The pericapsular nerve group (PENG) block is a relatively new regional anesthesia technique that targets the articular branches of the femoral, obturator, and accessory obturator nerves, providing analgesia to the anterior hip capsule.

This prospective study was conducted to compare the clinical effects of PENG block in patients undergoing partial hip prosthesis surgery under general anesthesia. A total of 48 patients aged between 18 and 75 years were included and divided into two groups: the PENG group (Group P), which received ultrasound-guided PENG block with 20 mL of 0.5% bupivacaine after induction of general anesthesia, and the control group (Group K), which received general anesthesia alone.

Demographic data, intraoperative anesthetic requirements, and postoperative parameters were recorded. The primary outcome measure was total tramadol consumption within the first 24 hours after surgery. Secondary outcomes included postoperative pain scores (VAS and NRS), hemodynamic parameters (mean arterial pressure and heart rate), remifentanil consumption, need for additional analgesia, bispectral index (BIS) values, patient comfort score, modified Aldrete recovery score, Riker agitation-sedation scale, and incidence of complications such as nausea, vomiting, hypotension, hypertension, and arrhythmia.

The results of this study are intended to evaluate the effectiveness of PENG block as a component of multimodal analgesia and to determine its impact on opioid consumption and postoperative recovery in patients undergoing hip surgery.

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
None

盲法说明

No masking was applied in this study.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 75 years
  • Patients scheduled for partial hip prosthesis surgery
  • Patients classified as ASA physical status I-III
  • Patients who provided written informed consent

排除标准

  • Known allergy to local anesthetics
  • Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
  • Infection at the injection site
  • Severe systemic disease (ASA IV or higher)
  • Cognitive impairment preventing reliable pain assessment
  • Refusal to participate in the study

研究组 & 干预措施

PENG Block Group

Experimental

Patients receiving ultrasound-guided PENG block after induction of general anesthesia.

干预措施: PENG Block (Procedure)

Control Group

Active Comparator

Control Group

干预措施: General Anesthesia (Procedure)

结局指标

主要结局

Total Tramadol Consumption Within 24 Hours After Surgery

时间窗: 24 hours postoperatively

Total amount of tramadol (mg) consumed by patients during the first 24 hours after surgery.

次要结局

  • Intraoperative Remifentanil Consumption(Intraoperative period)
  • Additional Analgesic Requirement(24 hours postoperatively)
  • Postoperative Complications(24 hours postoperatively)
  • Postoperative VAS Pain Scores(0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively)
  • Postoperative NRS Pain Scores(0, 10, 30, 60 minutes and 2, 4, 6, 12, 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yavuz Saygılı

Research Assistant in Anesthesiology

University of Gaziantep

研究点 (1)

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