Comparison of the Efficiency of Femur Nerve Block and Intravenous Analgesia Treatment in Hip Fracture Patients

Femoral Nerve Block Versus Intravenous Fentanyl for Pain Management in Emergency Department Patients With Hip Fracture: A Randomized, Double-Blind, Clinical Trial

It is well-established that hip fractures impose a significant medical, socioeconomic, and financial burden. In the elderly population, the associated mortality and morbidity are particularly pronounced: within one year following a hip fracture, mortality rates range from 20% to 30%; approximately one-third of patients require an elevated level of care, and only 30-40% retain the potential to fully recover and regain their pre-injury functional status. Consequently, strategies to enhance early outcomes in these patients are urgently needed. Reducing preoperative pain has been shown to improve patient satisfaction, facilitate the timing and effectiveness of physical therapy, shorten hospital stays, and support long-term functional recovery. Perioperative nerve blockade has demonstrated superior efficacy compared to systemic analgesia, traction, neurostimulation, and alternative medicine approaches. The advantages of peripheral nerve blocks include reduced pain scores, decreased opioid consumption, a lower risk of pneumonia, shorter time to ambulation, diminished postoperative cognitive dysfunction, and a more cost-effective analgesic regimen. This study seeks to evaluate the effects of femoral nerve block (FNB) on common hip fracture types within a trauma patient population. Specifically, we compared the efficacy of ultrasound-guided, single-injection femoral nerve block against prevalent hip fracture types prior to surgery, assessing outcomes longitudinally through changes in pain scores and opioid requirements.

Study Overview

• Status: Completed
• Conditions: Analgesia; Hip Fractures; Femoral Nerve
• Intervention / Treatment: Procedure: Femoral Nerve Block; Drug: IV Analgesia- Fentanyl

Detailed Description

Hip fractures constitute a significant medical and socioeconomic challenge, particularly among elderly populations. Epidemiological projections estimate a marked rise in the global incidence of hip fractures, with approximately 6.26 million cases anticipated by 2050. These injuries are associated with substantial morbidity and mortality, with one-year post-fracture mortality rates ranging from 20% to 30%. Furthermore, only 30% to 40% of survivors recover their pre-injury functional capacity, and many require long-term care, underscoring the profound impact of these injuries.

Effective pain management is pivotal in optimizing early outcomes for patients with hip fractures. Adequate analgesia not only enhances patient comfort but also facilitates the initiation of physical therapy, shortens hospital stays, and supports improved long-term functional recovery. Various pain control strategies, including systemic analgesia, traction, neurostimulation, and alternative therapies, have been employed. However, perioperative nerve blockade has demonstrated superior efficacy and broader patient benefits. Peripheral nerve blocks, such as the femoral nerve block (FNB), offer notable advantages, including reduced pain scores, decreased opioid consumption, lower incidence of pneumonia, enhanced mobilization, diminished risk of postoperative cognitive dysfunction, and reduced costs associated with analgesic regimens.

This randomized controlled trial seeks to evaluate the comparative efficacy of ultrasound-guided, single-injection femoral nerve block versus intravenous fentanyl for pain management in patients presenting with proximal femoral fractures in the emergency department. The study cohort comprises adult patients diagnosed with hip fractures-specifically femoral neck and intertrochanteric fractures-confirmed through radiological imaging. Participants will be randomly allocated to receive either an ultrasound-guided femoral nerve block with 20 mL of 0.5% bupivacaine or intravenous fentanyl at a dose of 1 mcg/kg.

Pain levels will be assessed using the standardized Numerical Rating Scale (NRS) at baseline (pre-intervention) and 20 minutes post-intervention. For patients with cognitive impairment, the Pain Assessment in Advanced Dementia (PAINAD) scale will serve as an alternative evaluation tool. Secondary outcomes include opioid consumption, patient satisfaction, length of stay in the emergency department, and adverse effects associated with each analgesic modality.

The study employs a double-blind methodology, ensuring that both participants and assessing clinicians remain unaware of treatment allocation. To maintain blinding, all participants will undergo two procedures: one active intervention and one placebo. In the intravenous fentanyl group, a placebo femoral block will be administered using 20 mL of normal saline, while in the FNB group, a placebo intravenous infusion (100 mL of normal saline) will be provided. This design minimizes bias in the assessment of efficacy and adverse effects.

The findings of this study are expected to inform the optimization of acute pain management strategies in emergency settings, potentially reducing opioid reliance, enhancing patient mobility, and improving overall clinical outcomes. By comparing these two analgesic approaches, this trial aims to identify the most effective and practical pain relief strategy for hip fracture patients prior to surgical intervention.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Pendik
    • Istanbul, Pendik, Turkey (Türkiye)
      • Marmara University Pendik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Radiologically confirmed proximal femur fracture (femoral neck or intertrochanteric fracture)
• Ability to provide informed consent or have a legal representative provide consent

Exclusion Criteria:

• Hemodynamic instability (SBP <90 mmHg, HR >120 bpm)
• Severe trauma requiring immediate surgical intervention (e.g., multiple trauma, head injury)
• Bleeding disorders or anticoagulation therapy (INR ≥2.5, platelet count <50,000/mm³)
• Known allergy to local anesthetics (bupivacaine) or opioids (fentanyl)
• Pregnancy
• Prior administration of local anesthetic blocks or systemic opioids before arrival
• Periprosthetic fractures or previous surgery on the affected hip

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral Nerve Block; Patients in this group receive an ultrasound-guided, single-injection femoral nerve block using 20 mL of 0.5% bupivacaine. This intervention aims to provide effective regional analgesia, reducing preoperative pain and opioid requirements. A placebo intravenous infusion (100 mL normal saline) is administered to maintain blinding.	Procedure: Femoral Nerve Block; Patients undergo an ultrasound-guided, single-injection femoral nerve block with 20 mL of 0.5% bupivacaine. This regional anesthesia technique targets the femoral nerve, providing effective pain relief while reducing opioid requirements.
Active Comparator: IV Analgesia-Fentanyl; Patients in this group receive intravenous fentanyl at 1 mcg/kg, diluted in 100 mL normal saline, for systemic pain control. To ensure blinding, a placebo femoral nerve block with 20 mL of normal saline is performed. Pain scores and opioid consumption are assessed to compare the efficacy of both approaches.	Drug: IV Analgesia- Fentanyl; Patients receive intravenous fentanyl at a dose of 1 mcg/kg, diluted in 100 mL normal saline, administered as a single dose for systemic analgesia. This intervention aims to control acute pain in hip fracture patients before surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Change	This study assesses pain score changes from baseline to 20 minutes post-intervention in hip fracture patients. For those without cognitive impairment, the Numerical Rating Scale (NRS) is used, ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating worse pain. The difference in NRS scores pre- and post-intervention evaluates the efficacy of ultrasound-guided femoral nerve block versus intravenous fentanyl. For cognitively impaired patients, the Pain Assessment in Advanced Dementia (PAINAD) scale is applied, also ranging from 0 (no pain) to 10 (severe pain), where higher scores reflect worse pain. PAINAD uses behavioral indicators like breathing and facial expression for those unable to self-report. Changes in PAINAD scores are analyzed similarly to assess treatment effectiveness.	Baseline (pre-intervention) and 20 minutes post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.	4 hours
Number of Participants With Rescue Analgesic Use	Following the intervention, patients were monitored for a 4-hour period to assess the need for rescue analgesia (intravenous fentanyl, tramadol, or morphine exc).	4 hours

Collaborators and Investigators

• Sponsor: Marmara University

Publications and helpful links

General Publications

• Altunbas E, Kudu E, Unal E, Sanri E, Karacabey S, Gunduz OH. Femoral nerve block vs IV fentanyl for hip fracture pain in the emergency department: A randomized double-blind clinical trial. Am J Emerg Med. 2025 Oct 24;99:359-364. doi: 10.1016/j.ajem.2025.10.044. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain control; Ultrasound guided analgesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Leg Injuries; Neurobehavioral Manifestations; Fractures, Bone; Femoral Fractures; Hip Injuries; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hip Fractures; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl
• Other Study ID Numbers: 09.2022.604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and/or analyzed during the current study are not publicy available, but are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No