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临床试验/NCT07667231
NCT07667231尚未招募不适用

Comparison Between Quadro-iliac Plane Block (QIPB) and Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve Block for Total Hip Arthroplasty: a Randomized Controlled Trial

Antalya City Hospital0 个研究点目标入组 60 人开始时间: 2026年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60

研究概览

简要总结

This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve(LFCN) block in patients undergoing total hip arthroplasty. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.

详细描述

Materials and Methods:

This prospective, randomized clinical trial will include patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective unilateral primary total hip arthroplasty unde spinal anesthesia. Before enrollment, all patients will be informed about the study protocol and written informed consent will be obtained. Patients will be instructed on the use of the Numeric Rating Scale (NRS) for postoperative pain assessment, where 0 represents no pain and 10 represents the worst pain imaginable.

Patients with contraindications to spinal anesthesia, allergy to local anesthetics, coagulopathy, infection at the injection site, chronic opioid use, pre-existing neurological deficits involving the lower extremities, cognitive impairment preventing reliable communication, revision or bilateral hip arthroplasty, and refusal to participate will be excluded from the study.

Patients will be randomly allocated to one of two study groups using a computer-generated randomization sequence (https://www.randomizer.org). Randomization will be performed by a team member not involved in patient management or outcome assessment. Allocation concealment will be achieved using sequentially numbered sealed opaque envelopes, which will be opened immediately before block performance.

Upon arrival in the operating room, standard monitoring including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry will be applied. Following intravenous access and preloading according to institutional practice, spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle under aseptic conditions. After confirmation of free cerebrospinal fluid flow, 12-15 mg of 0.5% hyperbaric bupivacaine will be administered intrathecally. Supplemental sedation with intravenous midazolam and/or propofol may be provided when required for patient comfort.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled for elective unilateral primary total hip arthroplasty
  • Surgery planned under spinal anesthesia
  • Ability to understand and use the Numeric Rating Scale
  • Written informed consent provided

排除标准

  • Refusal to participate
  • Revision total hip arthroplasty
  • Bilateral total hip arthroplasty
  • Contraindication to spinal anesthesia
  • Contraindication to peripheral nerve block
  • Known allergy to local anesthetics or study drugs
  • Coagulopathy or anticoagulant use incompatible with neuraxial/regional anesthesia
  • Infection at the block injection site
  • Pre-existing neurological deficit involving the operative lower extremity
  • Peripheral neuropathy
  • Chronic opioid use
  • Cognitive impairment or inability to communicate reliably
  • Severe hepatic or renal failure
  • Body mass index >35 kg/m²
  • Pregnancy

研究者

发起方
Antalya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Kılın

consultant anesthesiologist

Antalya City Hospital

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