Pericapsular Nerve Group Block Versus Femoral Nerve Block Study
2026년 7월 29일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
110
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Celal Kaya, MD
- 전화번호: 90 5435176760
- 이메일: c.kaya47@hotmail.com
연구 장소
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Istanbul, 터키 (Türkiye)
- 모병
- Taksim Training and Research Hospital
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연락하다:
- Guray Demir, Proffesor
- 전화번호: 90 5052113989
- 이메일: guraydemir@gmail.com
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연락하다:
- Celal Kaya, MD
- 전화번호: 90 5435176760
- 이메일: c.kaya47@hotmail.com
-
수석 연구원:
- Celal Kaya, MD
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Beyoglu
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Istanbul, Beyoglu, 터키 (Türkiye)
- 아직 모집하지 않음
- Taksim Training and Research Hospital
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연락하다:
- celal kaya, MD
- 전화번호: 90 5435176760
- 이메일: celalmadime@gmail.com
-
연락하다:
- Guray Demir, Proffesor
- 전화번호: 90 5052113989
- 이메일: guraydemir@gmail.com
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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활성 비교기: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Spinal Anesthesia Convenience Score (SACS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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First-Attempt Success of Spinal Anesthesia
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Celal Kaya, Taksim Training and Research Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 22일
기본 완료 (추정된)
2026년 12월 14일
연구 완료 (추정된)
2026년 12월 22일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 16일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-48670771-514.99-317908988
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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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아니
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