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

NCT ID: NCT06989047

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2026-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PENG Block Group

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.

Group Type: EXPERIMENTAL

Pericapsular Nerve Group (PENG) Block

Intervention Type: 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.

Femoral Nerve Block Group

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.

Group Type: ACTIVE_COMPARATOR

Femoral Nerve Block (FNB)

Intervention Type: 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.

Interventions

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 analgesic efficacy of the block.

Intervention Type: 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Khaled Radwan Ammar

Resident of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed K Ammar, M.B.B.Ch

Role: CONTACT

Mohamed_Khaled@med.asu.edu.eg

01153702277 ext. +2

Other Identifiers

FMASU MS49/2024

Identifier Type: -

Identifier Source: org_study_id