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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06862154
Enrollment
104
Registered
2025-03-06
Start date
2022-11-01
Completion date
2024-12-01
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Femoral Nerve, Hip Fractures

Keywords

Ultrasound guided analgesia, pain control

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.

Interventions

DRUGIV 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.

PROCEDUREFemoral 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Score ChangeBaseline (pre-intervention) and 20 minutes post-interventionThis 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.

Secondary

MeasureTime frameDescription
Number of Participants With Adverse Events4 hoursAdverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.
Number of Participants With Rescue Analgesic Use4 hoursFollowing the intervention, patients were monitored for a 4-hour period to assess the need for rescue analgesia (intravenous fentanyl, tramadol, or morphine exc).

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

The study recruited adult patients aged 18 years and older who presented to the emergency department of Marmara University Pendik Training and Research Hospital with radiologically confirmed unilateral hip fractures (femoral neck or proximal femur). Patients were enrolled between November 2022 and December 2024.

Participants by arm

ArmCount
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. 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.
52
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. 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.
52
Total104

Baseline characteristics

CharacteristicTotalFemoral Nerve BlockIV Analgesia-Fentanyl
Age, Continuous79 years78.5 years79 years
Cancer5 Participants4 Participants1 Participants
Chronic Heart Failure29 Participants15 Participants14 Participants
Chronic Kidney Disease9 Participants4 Participants5 Participants
Dementia/Alzheimer15 Participants8 Participants7 Participants
Diabetes Mellitus45 Participants19 Participants26 Participants
Diastolic Blood Pressure (mmHg)78 mmHg79 mmHg78 mmHg
Fracture Side
Left Side
55 Participants29 Participants26 Participants
Fracture Side
Right Side
49 Participants23 Participants26 Participants
Fracture Type
Inter trochanteric fracture
54 Participants25 Participants29 Participants
Fracture Type
Neck of femur
45 Participants25 Participants20 Participants
Fracture Type
Proximal femur
5 Participants2 Participants3 Participants
Hypertension67 Participants34 Participants33 Participants
Multiple Myeloma3 Participants0 Participants3 Participants
Other Diseases16 Participants7 Participants9 Participants
Pulse Rate84 beat per minute84 beat per minute85 beat per minute
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Turkey
104 Participants52 Participants52 Participants
Sex: Female, Male
Female
45 Participants27 Participants18 Participants
Sex: Female, Male
Male
59 Participants25 Participants34 Participants
Systolic Blood Pressure (mmHg)140 mmHg142 mmHg135 mmHg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 52
other
Total, other adverse events
0 / 5225 / 52
serious
Total, serious adverse events
0 / 523 / 52

Outcome results

Primary

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.

Time frame: Baseline (pre-intervention) and 20 minutes post-intervention

ArmMeasureValue (MEDIAN)
Femoral Nerve BlockPain Score Change4 units on a scale
IV Analgesia-FentanylPain Score Change2 units on a scale
Secondary

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.

Time frame: 4 hours

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Femoral Nerve BlockNumber of Participants With Adverse EventsHeadache0 Participants
Femoral Nerve BlockNumber of Participants With Adverse EventsNausea0 Participants
Femoral Nerve BlockNumber of Participants With Adverse EventsDizziness0 Participants
Femoral Nerve BlockNumber of Participants With Adverse EventsNone52 Participants
Femoral Nerve BlockNumber of Participants With Adverse EventsHypotension0 Participants
IV Analgesia-FentanylNumber of Participants With Adverse EventsNone24 Participants
IV Analgesia-FentanylNumber of Participants With Adverse EventsHypotension3 Participants
IV Analgesia-FentanylNumber of Participants With Adverse EventsHeadache5 Participants
IV Analgesia-FentanylNumber of Participants With Adverse EventsDizziness8 Participants
IV Analgesia-FentanylNumber of Participants With Adverse EventsNausea12 Participants
Secondary

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).

Time frame: 4 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Femoral Nerve BlockNumber of Participants With Rescue Analgesic Use11 Participants
IV Analgesia-FentanylNumber of Participants With Rescue Analgesic Use32 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026