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

NCT ID: NCT06862154

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-01

Brief Summary

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.

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.

Conditions

Hip Fractures; Analgesia; Femoral Nerve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Femoral Nerve Block

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

IV Analgesia- Fentanyl

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Sinan Karacabey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 41167010 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09.2022.604

Identifier Type: -

Identifier Source: org_study_id