Hip FracturesPhase 4NCT06862154
Comparison of the Efficiency of Femur Nerve Block and Intravenous Analgesia Treatment in Hip Fracture Patients
A Phase 4 study testing IV Analgesia- Fentanyl and Femoral Nerve Block in people with Hip Fractures and Analgesia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Analgesia, Femoral Nerve
- What is being tested?
- IV Analgesia- Fentanyl and Femoral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Dec 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik
About this study
Official title: 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.
Read the 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
- Being tested
- IV Analgesia- Fentanyl, Femoral Nerve Block
- Keywords
- Ultrasound guided analgesia, pain control
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Analgesia- FentanylDrug
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.
Femoral Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: IV Analgesia- Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and 20 minutes post-intervention
Secondary outcomes (2)
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.
Measured: 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).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Nov 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Karacabey, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862154
- Sponsor's protocol ID
- 09.2022.604
- Status last verified
- Nov 2025
- First submitted
- 1 Mar 2025
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicy available, but are available from the corresponding author on reasonable request.
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. 2026 Jan;99:359-364. doi: 10.1016/j.ajem.2025.10.044. Epub 2025 Oct 24.
PubMed 41167010