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临床试验/NCT06183528
NCT06183528招募中不适用

Effects of Pericapsular Nerve Group Block on Postoperative Recovery for Total Hip Arthroplasty

Umraniye Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9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
招募中
发起方
入组人数
60
试验地点
1
主要终点
postoperative pain score

研究概览

简要总结

The hypothesis of this study is that patients who undergo PENG block in before Total Hip Artroplasthy (THA) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

详细描述

This prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent THA surgery under spinal anaesthesia. Patients were divided into two groups as PENG block (n:30) and non-PENG block (n:30). PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered and surgery was initiated. The primary outcome of the study was to investigate the effect of preoperative PENG block application on postoperative pain, opioid requirement, mobilisation time, hip joint patency and length of hospital stay in patients undergoing THA surgery. The secondary outcome was to investigate the effect of PENG block on perioperative haemodynamics and postoperative side effects.

For multimodal analgesia, 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical wound incision line by the surgical team at the end of surgery. After tramadol 50 mg loading with PCA device, a basal rate of 5-10 mg/hour (20 mg bolus dose + 30 minutes lock time) is given with paracetamol 10 mg/kg iv (8 hours interval).

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)

入排标准

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

入选标准

  • •THA performed by posterior approach
  • •40-85 age range

排除标准

  • •Under 40 years of age, over 85 years of age,
  • •ASA 4 and above,
  • •Cognitive impairment (Alzheimer's disease, dementia, delirium etc.),
  • •Hip fracture,
  • •Application site infection,
  • •Allergy to local anaesthetic agents,
  • •Patients are non-consenting patients.

研究组 & 干预措施

PENG group

Active Comparator

PENG block was placed in the fascial plane between the pseudotendon and pubic ramus with USG in-plane technique, 20 ml of 0.5% bupivacaine was administered after spinal anaesthesia.

干预措施: Pericapsular Nerve Group (PENG) Block (Procedure)

non-PENG group

Placebo Comparator

group non-PENG, surgery was started without PENG block after spinal anaesthesia.

干预措施: Pericapsular Nerve Group (PENG) Block (Procedure)

结局指标

主要结局

postoperative pain score

时间窗: recovery room 30 min, 12., 24. and 48. hours in the postoperative period

VAS pain score

hip joint patency

时间窗: 24. hours

Measurement of joint movement angle with goniometer (angle)

mobilisation time

时间窗: 24 -48 hours

walking 5 steps with walker

total opioid consumption

时间窗: 48 hours

Tramadol total usage (mg)

次要结局

  • Perioperative haemodynamic data(T1: 30 minutes (min) after spinal anesthesia, T2: at the end of the surgical procedure, T3: at 30 minutes after recovery)
  • PENG block side effects(The first 48 hours after performing the PENG block)
  • length of hospital stay(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

Ass prof

Umraniye Education and Research Hospital

研究点 (1)

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