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PENG+LFCN Block vs QIPB for Total Hip Arthroplasty

2026年6月20日 更新者:Mustafa Kılın、Antalya City Hospital

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

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative pain scores
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative opioid consumption
時間枠: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
時間枠:Postoperative 3, 6, and 24 hours

Quadriceps motor block will be assessed using knee extension testing and graded as:

0 = normal strength

  1. = paresis
  2. = paralysis. Motor block incidence will be defined as the presence of paresis or paralysis.
Postoperative 3, 6, and 24 hours
Patient satisfaction
時間枠:Postoperative 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.
Postoperative 48 hours
Postoperative nausea and vomiting (PONV)
時間枠:Postoperative 48 hours
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Postoperative 48 hours
Falls
時間枠:Through postoperative day 2
Incidence of falls during the first 48 postoperative hours.
Through postoperative day 2
Length of hospital stay
時間枠:Through hospital discharge, up to 30 days
Number of days from surgery to hospital discharge.
Through hospital discharge, up to 30 days
Time to first ambulation
時間枠:Postoperative day 1
Time from the end of surgery to the first successful ambulation.
Postoperative day 1
Block performance time
時間枠:Periprocedural
Time from ultrasound probe placement to completion of local anesthetic injection.
Periprocedural
Block-related complications
時間枠: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

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月15日

一次修了 (推定)

2027年8月15日

研究の完了 (推定)

2027年9月15日

試験登録日

最初に提出

2026年6月13日

QC基準を満たした最初の提出物

2026年6月20日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月20日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • QİPBvsPENG+LFCN

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いいえ

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