PENG+LFCN Block vs QIPB for Total Hip Arthroplasty
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
研究概览
地位
详细说明
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.
Following successful spinal anesthesia, patients will receive either ultrasound-guided quadro-iliac plane block (QIPB) or ultrasound-guided pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block according to group allocation. All blocks will be performed by anesthesiologists experienced in regional anesthesia and familiar with both techniques.
All patients will receive the same multimodal postoperative analgesic regimen and standardized postoperative rehabilitation protocol. Postoperative pain scores at rest and during movement will be assessed using the NRS during the first 48 postoperative hours. Opioid consumption, incidence of quadriceps motor block, time to first ambulation, patient satisfaction, postoperative nausea and vomiting, falls, length of hospital stay, block performance time, and block-related complications will also be recorded.
Outcome assessments will be performed by investigators who are unaware of group allocation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:MUSTAFA KILIN, Consultant Anesthesiologists
- 电话号码:+905464569218
- 邮箱:mustafa.kilin90@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:quadro-iliac plane block (QIPB)
|
Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after spinal anesthesia.
Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.
|
|
有源比较器:pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve block
|
Participants in the PENG group will undergo an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia.
A total of 20 mL of 0.25% bupivacaine will be administered.
Participants in the LFCN group will undergo an ultrasound-guided lateral femoral cutaneous nerve block after spinal anesthesia.
A total of 10 mL of 0.25% bupivacaine will be administered.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain scores
大体时间:Postoperative 6, 24, 36, and 48 hours
|
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours.
Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.
|
Postoperative 6, 24, 36, and 48 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative opioid consumption
大体时间:Postoperative 24 and 48 hours
|
Total postoperative opioid consumption will be recorded and cumulative opioid consumption will be calculated at postoperative 24 and 48 hours.
|
Postoperative 24 and 48 hours
|
|
Incidence of quadriceps motor block
大体时间:Postoperative 3, 6, and 24 hours
|
Quadriceps motor block will be assessed using knee extension testing and graded as: 0 = normal strength
|
Postoperative 3, 6, and 24 hours
|
|
Patient satisfaction
大体时间:Postoperative 48 hours
|
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
|
Postoperative 48 hours
|
|
Postoperative nausea and vomiting (PONV)
大体时间:Postoperative 48 hours
|
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
|
Postoperative 48 hours
|
|
Falls
大体时间:Through postoperative day 2
|
Incidence of falls during the first 48 postoperative hours.
|
Through postoperative day 2
|
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Length of hospital stay
大体时间:Through hospital discharge, up to 30 days
|
Number of days from surgery to hospital discharge.
|
Through hospital discharge, up to 30 days
|
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Time to first ambulation
大体时间:Postoperative day 1
|
Time from the end of surgery to the first successful ambulation.
|
Postoperative day 1
|
|
Block performance time
大体时间:Periprocedural
|
Time from ultrasound probe placement to completion of local anesthetic injection.
|
Periprocedural
|
|
Block-related complications
大体时间:Through hospital discharge, up to 30 days
|
Hematoma Vascular puncture Local anesthetic systemic toxicity (LAST) Infection at the injection site
|
Through hospital discharge, up to 30 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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