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

NCT06989047 | Not Yet Recruiting

• 1 other identifier: FMASU MS49/2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Proximal Femur Fracture; Hip Fracture; Pain Management; Spinal Anesthesia

Keywords

Pericapsular Nerve Group Block (PENG); Femoral Nerve Block (FNB); Ultrasound-Guided Nerve Block; Spinal Anesthesia; Hip Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (2)

• Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) will be used to assess pain intensity during positioning for spinal anesthesia. The VAS is a 10 cm line where 0 indicates no pain and 10 indicates the worst imaginable pain. The score will be recorded immediately before spinal anesthesia after performing either the PENG block or femoral nerve block.

  Immediately before spinal anesthesia (within 15 minutes post-block)

• Time to First Rescue Analgesia

  The time (in hours) from the end of the nerve block to the first request for additional analgesia (nalbuphine 0.2 mg/kg IV) will be recorded for each patient.

  Within 24 hours postoperatively

Secondary Outcomes (3)

• Total Nalbuphine Consumption

  24 hours postoperatively

• Mean Arterial Pressure (MAP) Changes

  From baseline up to 24 hours postoperatively

• Patient Satisfaction Score

  At 24 hours postoperatively

Study Arms (2)

PENG Block Group

EXPERIMENTAL

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 analgesic efficacy of the block.

Procedure: Pericapsular Nerve Group (PENG) Block

Femoral Nerve Block Group

ACTIVE COMPARATOR

Assigned Interventions: Procedure/Surgery: Femoral Nerve Block (FNB) An ultrasound-guided nerve block targeting the femoral nerve, performed with an in-plane ultrasound approach under sterile conditions, identifying the nerve lateral to the femoral artery. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used for nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct analgesic agent.

Procedure: Femoral Nerve Block (FNB)

Interventions

Pericapsular Nerve Group (PENG) Block PROCEDURE

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 analgesic efficacy of the block.

PENG Block Group

Femoral Nerve Block (FNB) PROCEDURE

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.

Femoral Nerve Block Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Proximal Femoral Fractures; Hip Fractures; Agnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mohamed K Ammar, M.B.B.Ch

CONTACT

01153702277; Mohamed_Khaled@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 25, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share