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Not yet recruiting NCT06989047

Ultrasound-Guided PENG Block vs Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Hip Fracture Surgery

No phase Interventional Proximal Femur Fracture Hip Fracture Pain Management Spinal Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pericapsular Nerve Group (PENG) Block, Femoral Nerve Block (FNB).
Who it may be relevant to
Registry conditions: Proximal Femur Fracture, Hip Fracture, Pain Management, Spinal Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Study of Preoperative Ultrasound-Guided Pericapsular Nerve Group Block and Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Proximal Femur Fracture Fixation

Overview

This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication. A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.

Interventions

  • Procedure Pericapsular Nerve Group (PENG) Block
    Assigned Interventions: Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analg
  • Procedure Femoral Nerve Block (FNB)
    An ultrasound-guided nerve block targeting the femoral nerve to provide analgesia before spinal anesthesia in proximal femur fracture surgery. Administered using 30 ml of 0.25% bupivacaine and 5 ml of 10% magnesium sulfate (500 mg). The block is performed with an in-plane ultrasound approach, identifying the femoral nerve lateral to the femoral artery under sterile conditions.

Primary outcome measures

  • Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS) [Time frame: Immediately before spinal anesthesia (within 15 minutes post-block)]
  • Time to First Rescue Analgesia [Time frame: Within 24 hours postoperatively]
Secondary outcome measures (3)
  • Total Nalbuphine Consumption [Time frame: 24 hours postoperatively]
  • Mean Arterial Pressure (MAP) Changes [Time frame: From baseline up to 24 hours postoperatively]
  • Patient Satisfaction Score [Time frame: At 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Scheduled for proximal femur fracture fixation under spinal anesthesia
  • Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Provided written informed consent

Exclusion criteria

  • Coagulopathy
  • Local infection at the injection site
  • Known allergy to local anesthetics or magnesium sulfate
  • Severe cardiopulmonary disease \[American Society of Anesthesiologists (ASA) ≥ IV\]
  • Preexisting diabetic or other neuropathies
  • Chronic opioid use
  • Contraindication to spinal anesthesia
  • Cognitive impairment or inability to comprehend Visual Analog Scale (VAS)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06989047 · FMASU MS49/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗