Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures

NCT07130006 | Not Yet Recruiting Phase 4

• 1 other identifier: 2181-147/01-06/LJ.Z.-25.02.
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are:

• which peripheral nerve block is the best regarding analgesia
• which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia?
• which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous?
• which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy?
• what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery?
• what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution. All respondents will, in addition to obligatory intraoperative monitoring,:
• be thoroughly examined by anesthesiologists before surgery
• be closely monitored after surgery, until their hospital discharge.

Conditions

Fractures, Hip; Femoral Neck Fractures; Intertrochanteric Fractures; Subtrochanteric Fractures; Aged; Frail Older Adults; Elderly

Keywords

elderly; ultrasound-guided; peripheral nerve blocks; intravenous fentanyl; spinal anaesthesia; EQ-5D-5L; visual analog scale; pain at rest; dynamic pain; hip fracture surgery

Outcome Measures

Primary Outcomes (1)

• Pain relief

  The primary outcome measures of this research is pain relief after the administration of peripheral nerve block. Pain will be measured using VAS scale, as a part of one of EQ-5D-5L, at rest and during passive 15˚ leg rising. VAS is the most commonly used scale for pain measurement. VAS ratings (100-mm) of 0 to 4 mm will be considered as no pain; 5 to 44 mm as mild pain; 45 to 74 mm as moderate pain and 75 - 100 mm as severe pain. Cut off values for VAS vary depending on the context and the population. However, 33% decrease in pain is a reasonable standard for determining that a treatment provides meaningful relief.

  20 minutes after application of the local anesthetic

Secondary Outcomes (10)

• Health Outcome

  before application of the block, 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation.

• Time for the performance of peripheral nerve block

  Before surgery.

• Time for the performance of spinal anesthesia in a sitting position

  Before surgery

• Rescue analgesics

  After surgery, up to 48 hours

• Duration of peripheral nerve blocks

  20 minutes after the block and 6 hours, 24 hours and 48 hours post surgery

Study Arms (8)

Intracapsular hip fracture FEMORAL BLOCK

ACTIVE COMPARATOR

Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.

Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesia

Intracapsular hip fracture PENG BLOCK

ACTIVE COMPARATOR

Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.

Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesia

Intracapsular hip fracture FASCIA ILIACA BLOCK

ACTIVE COMPARATOR

Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.

Procedure: FIC peripheral nerve block with spinal anesthesia

Intracapsular hip fracture FENTANYL

ACTIVE COMPARATOR

Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for partial endoprothesis of hip fracture.

Procedure: Fentanyl (IV) with spinal anesthesia

Extracapsular hip fracture FEMORAL BLOCK

ACTIVE COMPARATOR

Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture.

Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesia

Extracapsular hip fracture PENG BLOCK

ACTIVE COMPARATOR

Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture.

Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesia

Extracapsular hip fracture FASCIA ILIACA BLOCK

ACTIVE COMPARATOR

Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for osteosinthesis of hip fracture.

Procedure: FIC peripheral nerve block with spinal anesthesia

Extracapsular hip fracture FENTANYL

ACTIVE COMPARATOR

Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for osteosinthesis of hip fracture.

Procedure: Fentanyl (IV) with spinal anesthesia

Interventions

PENG and LFCN peripheral nerve blocks with spinal anesthesia PROCEDURE

At first, one needs to detect hyperechogenic iliopsoas notch and psoas tendon, between anterior inferior iliac spine and iliopubic eminence. Then needle needs to be inserted in-plane and 20mL of levobupivacaine 0.25% administered along the fascial plane. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Curvilinear probe will be used. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.

Extracapsular hip fracture PENG BLOCK; Intracapsular hip fracture PENG BLOCK

FN and LFCN peripheral nerve blocks with spinal anesthesia PROCEDURE

At first, one needs to detect both femoral artery and vein medial to it. Then needle needs to be inserted in-plane and 15mL of levobupivacaine 0.5% need to be administered underneath fascia iliaca, lateral to femoral nerve. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles, where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Linear probe will be used. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.

Extracapsular hip fracture FEMORAL BLOCK; Intracapsular hip fracture FEMORAL BLOCK

FIC peripheral nerve block with spinal anesthesia PROCEDURE

Suprainguinal approach will be performed. At first, one needs to detect anterior inferior iliac spine, sartorius and internal oblique muscles creating a bow-tie. Deep circumflex iliac artery will be seen between transversus abdominis and iliacus muscle. Then needle needs to be inserted in-plane and 40mL of levobupivacaine 0.25% administered along the fascial plane so that fascia separates from iliacus muscle. The needle is inserted from caudal to cranial, to achieve the widest possible spread of local anesthetic under the fascia, to the cranial side, as this reaches both lateral femoral cutaneous nerve and femoral nerve. The spread of anesthetic will appear hypoechoic on ultrasound. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.

Extracapsular hip fracture FASCIA ILIACA BLOCK; Intracapsular hip fracture FASCIA ILIACA BLOCK

Fentanyl (IV) with spinal anesthesia PROCEDURE

A total dose of 2 mcg/kg of fentanyl will be given to patients before positioning to spinal. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3/4 level using 25 G spinal needle.

Extracapsular hip fracture FENTANYL; Intracapsular hip fracture FENTANYL

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both sexes
• years old and older
• diagnosed with a hip fracture resulting from low-energy trauma
• scheduled surgery.

You may not qualify if:

• polytraumatized patients
• dementia and acute psychosis patients
• patients for whom spinal anesthesia is contraindicated
• patients with severe renal failure
• patients for whom intravenous administration of tranexamic acid is contraindicated
• patients with proven allergy and contraindications to dexamethasone, non-steroidal anti-rheumatic drugs, opioid analgesics, magnesium sulfate.

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital of Split

Split, 21000, Croatia

Location

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MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Interventions

Anesthesia, Spinal; Fentanyl

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ana Saric Jadrijev, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  PRINCIPAL INVESTIGATOR

• Ruben Kovac, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Marija Kljucevic, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Petra Bajto, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Meri Mirceta, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Ana Maria Mitar, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Ana Bego, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Josipa Modric, MD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Nikola Delic, MD, PhD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Toni Kljakovic-Gaspic, MD, PhD

  Department of Anaesthesiology and Intensive Care, University Hospital of Split

  STUDY CHAIR

• Nikola Kljucevic, MD, PhD

  Department of Surgery, University Hospital of Split

  STUDY CHAIR

• Boris Luksic, MD, PhD

  Department of Surgery, University Hospital of Split

  STUDY CHAIR

Central Study Contacts

Ana Saric Jadrijev, MD

CONTACT

385981788627; ana_saric@yahoo.com

Ana Maria Mitar, MD

CONTACT

385916026084; anamaria.mitar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Respondents will not know to which group they have been randomized, nor will the surgeons, anesthesiology residents, nor nurses on the ward. Anesthesiologists will be familiar with all the items and will therefore be considered as the study supervisors.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anaesthesiology, Reanimatology and Intensive Medicine Specialist, Principal Investigator

Model Details: Factorial randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: August 19, 2025
• Study Start: August 30, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CR (1)