NCT07717463

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

July 6, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

Expected
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 6, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Hip FracturePericapsular Nerve Group BlockFemoral Nerve BlockRegional AnesthesiaSpinal AnesthesiaHemodynamic Stability

Outcome Measures

Primary Outcomes (1)

  • Spinal Anesthesia Convenience Score (SACS)

    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.

    During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)

Secondary Outcomes (11)

  • First-Attempt Success of Spinal Anesthesia

    During the spinal anesthesia procedure.

  • Number of Spinal Needle Insertion Attempts

    During the spinal anesthesia procedure.

  • Duration of Spinal Anesthesia Procedure

    During the spinal anesthesia procedure.

  • Anxiety Score

    Before peripheral nerve block, 30 minutes after block placement, and immediately before surgical incision (after spinal anesthesia).

  • Patient Satisfaction

    Postoperative Day 0 (before discharge from the post-anesthesia care unit [PACU])

  • +6 more secondary outcomes

Study Arms (2)

PENG Block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-Guided Pericapsular Nerve Group (PENG) BlockProcedure: Spinal Anesthesia (bupivacaine)

Femoral Nerve Block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-Guided Femoral Nerve BlockProcedure: Spinal Anesthesia (bupivacaine)

Interventions

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.

Femoral Nerve Block

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.

PENG Block

Standard spinal anesthesia performed after the assigned peripheral nerve block using intrathecal hyperbaric bupivacaine according to the study protocol.

Femoral Nerve BlockPENG Block

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taksim Training and Research Hospital

Istanbul, Beyoglu, Turkey (Türkiye)

NOT YET RECRUITING

Taksim Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hip Fractures

Interventions

Dental OcclusionAnesthesia, SpinalBupivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Celal Kaya

    Taksim Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 21, 2026

Study Start

July 22, 2026

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 22, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations