Pericapsular Nerve Group Block Versus Femoral Nerve Block Study
2026年7月29日 更新者：Taksim Egitim ve Arastirma Hastanesi
Comparison of Preoperative Pericapsular Nerve Group (PENG) Block Versus Femoral Nerve Block for Optimizing Spinal Anaesthesia in Proximal Femur Fracture Surgery: A Prospective Randomized Controlled Trial
Hip fractures are common in older adults and are often associated with severe pain, making it difficult for patients to sit for spinal anesthesia before surgery.
Peripheral nerve blocks may improve pain control and facilitate patient positioning, but it remains uncertain whether the Pericapsular Nerve Group (PENG) block provides advantages over the traditional femoral nerve block during the spinal anesthesia procedure.
調査の概要
状態
募集
条件
詳細な説明
Hip fractures are among the most common injuries in older adults and are associated with substantial morbidity, mortality, and healthcare utilization. Spinal anesthesia is frequently used for surgical repair of proximal femur fractures because of its favorable safety profile in elderly patients. However, severe pain caused by the fracture often makes positioning for spinal anesthesia difficult, resulting in patient discomfort, prolonged procedure time, multiple needle insertion attempts, and increased procedural complexity.
Peripheral nerve blocks are increasingly used before spinal anesthesia to improve analgesia and facilitate patient positioning. The femoral nerve block (FNB) has long been established as an effective regional anesthesia technique for patients with hip fractures. More recently, the ultrasound-guided Pericapsular Nerve Group (PENG) block has been introduced as a motor-sparing technique targeting the articular branches of the femoral, obturator, and accessory obturator nerves that innervate the anterior hip capsule. Previous studies have demonstrated that the PENG block provides effective analgesia during positioning for spinal anesthesia and may offer superior pain relief compared with conventional techniques. However, evidence comparing the effects of PENG block and femoral nerve block on the technical performance of spinal anesthesia and perioperative hemodynamic stability remains limited.
This prospective, randomized controlled trial is designed to compare ultrasound-guided PENG block with ultrasound-guided femoral nerve block in patients undergoing surgery for proximal femur fracture under spinal anesthesia. The study will evaluate whether PENG block improves procedural conditions for spinal anesthesia compared with femoral nerve block while also assessing perioperative analgesia and hemodynamic responses.
The study hypothesis is that preoperative PENG block will provide better procedural conditions for spinal anesthesia than femoral nerve block by improving patient positioning, reducing pain during positioning, facilitating spinal needle placement, decreasing the need for supplemental analgesic or sedative medication, and contributing to greater perioperative hemodynamic stability.
研究の種類
介入
入学 (推定)
110
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
- 名前：Celal Kaya, MD
- 電話番号：90 5435176760
- メール：c.kaya47@hotmail.com
研究場所
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Istanbul、トルコ（Türkiye）
- 募集
- Taksim Training and Research Hospital
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コンタクト：
- Guray Demir, Proffesor
- 電話番号：90 5052113989
- メール：guraydemir@gmail.com
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コンタクト：
- Celal Kaya, MD
- 電話番号：90 5435176760
- メール：c.kaya47@hotmail.com
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主任研究者：
- Celal Kaya, MD
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Beyoglu
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Istanbul、Beyoglu、トルコ（Türkiye）
- まだ募集していません
- Taksim Training and Research Hospital
-
コンタクト：
- celal kaya, MD
- 電話番号：90 5435176760
- メール：celalmadime@gmail.com
-
コンタクト：
- Guray Demir, Proffesor
- 電話番号：90 5052113989
- メール：guraydemir@gmail.com
-
-
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:
- Adults aged 50 years or older.
- Diagnosis of proximal femoral fracture.
- Scheduled to undergo surgical repair under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to provide written informed consent.
Exclusion Criteria:
- Refusal to participate or inability to provide informed consent.
- Coagulopathy or contraindication to spinal anesthesia or peripheral nerve block.
- Local infection at the planned injection site.
- Known allergy or hypersensitivity to local anesthetics.
- Pre-existing neurological disease affecting lower extremity function or sensory assessment.
- Cognitive impairment preventing reliable study participation or outcome assessment.
- Previous lumbar spine surgery.
- Polytrauma.
- Body mass index (BMI) <18 kg/m² or >40 kg/m².
- Current anticoagulant therapy that precludes neuraxial anesthesia or peripheral nerve block according to institutional practice.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：PENG Block
Participants will receive a preoperative ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery.
Spinal anesthesia will subsequently be performed according to the standardized study protocol.
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Ultrasound-guided PENG block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
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アクティブコンパレータ：Femoral Nerve Block
Participants will receive a preoperative ultrasound-guided femoral nerve block with 20 mL of 0.25% bupivacaine before spinal anesthesia for proximal femur fracture surgery.
Spinal anesthesia will subsequently be performed according to the standardized study protocol.
|
Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.
Ultrasound-guided femoral nerve block performed before spinal anesthesia using 20 mL of 0.25% bupivacaine to provide analgesia for patients undergoing surgery for proximal femur fracture.
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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 |
|---|---|---|
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Spinal Anesthesia Convenience Score (SACS)
時間枠：During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
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Spinal anesthesia convenience will be assessed using the Spinal Anesthesia Convenience Score (SACS), a composite clinical score evaluating the ease of spinal anesthesia based on anatomical landmark palpation, patient cooperation, sitting position quality, pain during passive hip flexion, and pain while maintaining the sitting position.
Total scores range from 0 to 11, with higher scores indicating easier spinal anesthesia conditions.
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During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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First-Attempt Success of Spinal Anesthesia
時間枠：During the spinal anesthesia procedure.
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The proportion of participants in whom successful intrathecal access is achieved on the first needle insertion attempt.
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During the spinal anesthesia procedure.
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Number of Spinal Needle Insertion Attempts
時間枠：During the spinal anesthesia procedure.
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The total number of spinal needle insertion attempts required to achieve successful spinal anesthesia.
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During the spinal anesthesia procedure.
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Duration of Spinal Anesthesia Procedure
時間枠：During the spinal anesthesia procedure.
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Time from the beginning of patient positioning until completion of spinal anesthesia and return to the supine position, measured in minutes.
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During the spinal anesthesia procedure.
|
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Anxiety Score
時間枠：Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
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Patient anxiety will be assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no anxiety) to 10 (maximum anxiety).
Lower scores indicate less anxiety.
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Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).
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Patient Satisfaction
時間枠：Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
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Patient satisfaction with the anesthesia process will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])
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Anesthesiologist Satisfaction
時間枠：Immediately after completion of spinal anesthesia.
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The anesthesiologist's satisfaction with procedural conditions will be assessed using a Numeric Rating Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Immediately after completion of spinal anesthesia.
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Perioperative Hemodynamic Parameters
時間枠：Before peripheral nerve block; 1, 5, 10, 15, and 30 minutes after block placement; and 1, 5, 10, 15, and 30 minutes after spinal anesthesia.
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Mean arterial blood pressure will be recorded throughout the perioperative period.
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Before peripheral nerve block; 1, 5, 10, 15, and 30 minutes after block placement; and 1, 5, 10, 15, and 30 minutes after spinal anesthesia.
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Incidence of Hypotension
時間枠：From spinal anesthesia until 30 minutes after surgery completed.
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Hypotension is defined as a mean arterial pressure below 65 mmHg.
The proportion of participants experiencing hypotension will be recorded.
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From spinal anesthesia until 30 minutes after surgery completed.
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Vasopressor Requirement
時間枠：From spinal anesthesia until 30 minutes after surgery completed.
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Total intravenous ephedrine dose administered for the treatment of hypotension, measured in milligrams.
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From spinal anesthesia until 30 minutes after surgery completed.
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Additional Analgesic Medication Requirement
時間枠：During the spinal anesthesia procedure.
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Total doses of intravenous fentanyl (micrograms) administered during positioning for spinal anesthesia.
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During the spinal anesthesia procedure.
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Additional Sedative Medication Requirement
時間枠：During the spinal anesthesia procedure.
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Total doses of intravenous midazolam (milligrams) administered during positioning for spinal anesthesia.
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During the spinal anesthesia procedure.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Celal Kaya、Taksim Training and Research Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Messina A, La Via L, Milani A, Savi M, Calabro L, Sanfilippo F, Negri K, Castellani G, Cammarota G, Robba C, Morenghi E, Astuto M, Cecconi M. Spinal anesthesia and hypotensive events in hip fracture surgical repair in elderly patients: a meta-analysis. J Anesth Analg Crit Care. 2022 May 8;2(1):19. doi: 10.1186/s44158-022-00047-6.
- Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
- Erten E, Kara U, Simsek F, Eskin MB, Bilekli AB, Ocal N, Senkal S, Ozdemirkan I. Comparison of pericapsular nerve group block and femoral nerve block in spinal anesthesia position analgesia for proximal femoral fractures in geriatric patients: a randomized clinical trial. Ulus Travma Acil Cerrahi Derg. 2023 Dec;29(12):1368-1375. doi: 10.14744/tjtes.2023.33389.
- Lin DY, Brown B, Morrison C, Kroon HM, Jaarsma RL. Pericapsular nerve group block results in a longer analgesic effect and shorter time to discharge than femoral nerve block in patients after hip fracture surgery: a single-center double-blinded randomized trial. J Int Med Res. 2022 Mar;50(3):3000605221085073. doi: 10.1177/03000605221085073.
- Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
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 (実際)
2026年7月22日
一次修了 (推定)
2026年12月14日
研究の完了 (推定)
2026年12月22日
試験登録日
最初に提出
2026年7月6日
QC基準を満たした最初の提出物
2026年7月16日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月31日
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- E-48670771-514.99-317908988
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
There is no current plan to share individual participant data (IPD).
Future data sharing may be considered upon reasonable request and subject to approval by the sponsor, institutional policies, and applicable ethical and legal requirements.
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