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Hip FracturesNCT07717463

Pericapsular Nerve Group Block Versus Femoral Nerve Block Study

A study testing Ultrasound-Guided Pericapsular Nerve Group (PENG) Block, Ultrasound-Guided Femoral Nerve Block and Spinal Anesthesia (bupivacaine) in people with Hip Fractures, run by Taksim Egitim ve Arastirma Hastanesi at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Ultrasound-Guided Pericapsular Nerve Group (PENG) Block, Ultrasound-Guided Femoral Nerve Block and Spinal Anesthesia (bupivacaine)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesTurkey (Türkiye)
Study dates
22 Jul 2026to 22 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Celal Kaya, MD contact

90 5435176760

c.kaya47@hotmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Taksim Training and Research Hospital

    Istanbul, Beyoglu

    celal kaya, MD, 90 5435176760, celalmadime@gmail.com

    Guray Demir, Proffesor, 90 5052113989, guraydemir@gmail.com

    Not yet recruiting
  • Taksim Training and Research Hospital

    Istanbul

    Celal Kaya, MD, 90 5435176760, c.kaya47@hotmail.com

    Guray Demir, Proffesor, 90 5052113989, guraydemir@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Hip Fractures
Being tested
Ultrasound-Guided Pericapsular Nerve Group (PENG) Block, Ultrasound-Guided Femoral Nerve Block, Spinal Anesthesia (bupivacaine)
Keywords
Hip Fracture, Pericapsular Nerve Group Block, Femoral Nerve Block, Regional Anesthesia, Spinal Anesthesia, Hemodynamic Stability
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Pericapsular Nerve Group (PENG) BlockProcedure or surgery

    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.

  • Ultrasound-Guided Femoral Nerve BlockProcedure or surgery

    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.

  • Spinal Anesthesia (bupivacaine)Procedure or surgery

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

Study groups in NCT07717463
Study groupRoleWhat they receive
PENG BlockActive comparatorParticipants 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.
Receives: Procedure: Ultrasound-Guided Pericapsular Nerve Group (PENG) Block; Procedure: Spinal Anesthesia (bupivacaine)
Femoral Nerve BlockActive comparatorParticipants 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.
Receives: Procedure: Ultrasound-Guided Femoral Nerve Block; Procedure: Spinal Anesthesia (bupivacaine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)
  1. First-Attempt Success of Spinal Anesthesia

    The proportion of participants in whom successful intrathecal access is achieved on the first needle insertion attempt.

    Measured: During the spinal anesthesia procedure.

  2. Number of Spinal Needle Insertion Attempts

    The total number of spinal needle insertion attempts required to achieve successful spinal anesthesia.

    Measured: During the spinal anesthesia procedure.

  3. Duration of Spinal Anesthesia Procedure

    Time from the beginning of patient positioning until completion of spinal anesthesia and return to the supine position, measured in minutes.

    Measured: During the spinal anesthesia procedure.

  4. Anxiety Score

    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.

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

  5. Patient Satisfaction

    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.

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

  6. Anesthesiologist Satisfaction

    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.

    Measured: Immediately after completion of spinal anesthesia.

  7. Perioperative Hemodynamic Parameters

    Mean arterial blood pressure will be recorded throughout the perioperative period.

    Measured: 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.

  8. Incidence of Hypotension

    Hypotension is defined as a mean arterial pressure below 65 mmHg. The proportion of participants experiencing hypotension will be recorded.

    Measured: From spinal anesthesia until 30 minutes after surgery completed.

  9. Vasopressor Requirement

    Total intravenous ephedrine dose administered for the treatment of hypotension, measured in milligrams.

    Measured: From spinal anesthesia until 30 minutes after surgery completed.

  10. Additional Analgesic Medication Requirement

    Total doses of intravenous fentanyl (micrograms) administered during positioning for spinal anesthesia.

    Measured: During the spinal anesthesia procedure.

  11. Additional Sedative Medication Requirement

    Total doses of intravenous midazolam (milligrams) administered during positioning for spinal anesthesia.

    Measured: During the spinal anesthesia procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start22 Jul 2026
  3. Primary completion14 Dec 2026 (estimated)
  4. Study completion22 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717463
Sponsor's protocol ID
E-48670771-514.99-317908988
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 37386657
  • 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.

    PubMed 30063657
  • 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.

    PubMed 20006206
  • 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.

    PubMed 38073453
  • 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.

    PubMed 35291842
  • 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.

    PubMed 37715173

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Pericapsular Nerve Group (PENG) Block, Ultrasound-Guided Femoral Nerve Block and Spinal Anesthesia (bupivacaine) in people with Hip Fractures, run by Taksim Egitim ve Arastirma Hastanesi at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Celal Kaya, MD (90 5435176760, c.kaya47@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spinal Anesthesia Convenience Score (SACS) (time frame: During spinal anesthesia procedure (immediately after patient positioning and before initiation of surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717463, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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Clinical Trial NCT07717463 | AzTrials