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

NCT06862154 | Completed Phase 4 Results

• 1 other identifier: 09.2022.604
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Analgesia; Femoral Nerve

Keywords

Ultrasound guided analgesia; pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Adverse Events

  4 hours

• Number of Participants With Rescue Analgesic Use

  4 hours

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

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

IV Analgesia-Fentanyl

ACTIVE COMPARATOR

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

Interventions

Femoral Nerve Block 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.

Femoral Nerve Block

IV Analgesia- Fentanyl 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.

IV Analgesia-Fentanyl

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Location

Related Publications (1)

• 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. 2026 Jan;99:359-364. doi: 10.1016/j.ajem.2025.10.044. Epub 2025 Oct 24.

  PMID: 41167010 DERIVED

MeSH Terms

Conditions

Hip Fractures; Agnosia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

First, since patients' lengths of stay in the emergency department varied, we recorded the four hours after treatment for rescue analgesia. Understanding the effect of FNB on opioid consumption would have been improved by extending this period. Second, potential side effects resulting from the treatment modalities administered (e.g. nausea, leg numbness) may have compromised treatment blinding for the researchers.

Results Point of Contact

• Title: Dr. Emre Kudu
• Organization: Marmara University School of Medicine

dr.emre.kudu@gmail.com

+902166254545

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a double-blind, randomized controlled design to compare ultrasound-guided femoral nerve block (FNB) and intravenous fentanyl for pain management in hip fracture patients. To maintain blinding, all patients receive two interventions: one active treatment and one placebo. The FNB group receives an active femoral nerve block (bupivacaine) and a placebo IV infusion (saline), while the IV fentanyl group receives active IV fentanyl and a placebo femoral block (saline). A non-blinded investigator prepares all syringes and IV bags, labeled as "Treatment A" and "Treatment B", ensuring that the patients, treating physicians, and outcome assessors remain blinded. Pain assessments and opioid use are recorded by a blinded investigator. This rigorous masking protocol minimizes bias and enhances the validity of the study's findings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)