Trial Outcomes & Findings for Comparison of the Efficiency of Femur Nerve Block and Intravenous Analgesia Treatment in Hip Fracture Patients (NCT NCT06862154)

Last Updated: 2025-12-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

104 participants

Primary outcome timeframe

Baseline (pre-intervention) and 20 minutes post-intervention

Results posted on

2025-12-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	52	52
Overall Study COMPLETED	52	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femoral Nerve Block n=52 Participants 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.	IV Analgesia-Fentanyl n=52 Participants 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.	Total n=104 Participants Total of all reporting groups
Age, Continuous	78.5 years n=52 Participants	79 years n=52 Participants	79 years n=104 Participants
Sex: Female, Male Female	27 Participants n=52 Participants	18 Participants n=52 Participants	45 Participants n=104 Participants
Sex: Female, Male Male	25 Participants n=52 Participants	34 Participants n=52 Participants	59 Participants n=104 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	52 Participants n=52 Participants	52 Participants n=52 Participants	104 Participants n=104 Participants
Hypertension	34 Participants n=52 Participants	33 Participants n=52 Participants	67 Participants n=104 Participants
Diabetes Mellitus	19 Participants n=52 Participants	26 Participants n=52 Participants	45 Participants n=104 Participants
Chronic Heart Failure	15 Participants n=52 Participants	14 Participants n=52 Participants	29 Participants n=104 Participants
Chronic Kidney Disease	4 Participants n=52 Participants	5 Participants n=52 Participants	9 Participants n=104 Participants
Cancer	4 Participants n=52 Participants	1 Participants n=52 Participants	5 Participants n=104 Participants
Dementia/Alzheimer	8 Participants n=52 Participants	7 Participants n=52 Participants	15 Participants n=104 Participants
Multiple Myeloma	0 Participants n=52 Participants	3 Participants n=52 Participants	3 Participants n=104 Participants
Other Diseases	7 Participants n=52 Participants	9 Participants n=52 Participants	16 Participants n=104 Participants
Systolic Blood Pressure (mmHg)	142 mmHg n=52 Participants	135 mmHg n=52 Participants	140 mmHg n=104 Participants
Diastolic Blood Pressure (mmHg)	79 mmHg n=52 Participants	78 mmHg n=52 Participants	78 mmHg n=104 Participants
Pulse Rate	84 beat per minute n=52 Participants	85 beat per minute n=52 Participants	84 beat per minute n=104 Participants
Fracture Side Right Side	23 Participants n=52 Participants	26 Participants n=52 Participants	49 Participants n=104 Participants
Fracture Side Left Side	29 Participants n=52 Participants	26 Participants n=52 Participants	55 Participants n=104 Participants
Fracture Type Inter trochanteric fracture	25 Participants n=52 Participants	29 Participants n=52 Participants	54 Participants n=104 Participants
Fracture Type Neck of femur	25 Participants n=52 Participants	20 Participants n=52 Participants	45 Participants n=104 Participants
Fracture Type Proximal femur	2 Participants n=52 Participants	3 Participants n=52 Participants	5 Participants n=104 Participants

PRIMARY outcome

Timeframe: Baseline (pre-intervention) and 20 minutes post-intervention

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=52 Participants 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.	IV Analgesia-Fentanyl n=52 Participants 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.
Pain Score Change	4 units on a scale Interval 3.0 to 5.0	2 units on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 4 hours

Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=52 Participants 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.	IV Analgesia-Fentanyl n=52 Participants 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.
Number of Participants With Adverse Events None	52 Participants	24 Participants
Number of Participants With Adverse Events Hypotension	0 Participants	3 Participants
Number of Participants With Adverse Events Headache	0 Participants	5 Participants
Number of Participants With Adverse Events Dizziness	0 Participants	8 Participants
Number of Participants With Adverse Events Nausea	0 Participants	12 Participants

SECONDARY outcome

Timeframe: 4 hours

Following the intervention, patients were monitored for a 4-hour period to assess the need for rescue analgesia (intravenous fentanyl, tramadol, or morphine exc).

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=52 Participants 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.	IV Analgesia-Fentanyl n=52 Participants 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.
Number of Participants With Rescue Analgesic Use	11 Participants	32 Participants

Adverse Events

Femoral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV Analgesia-Fentanyl

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Femoral Nerve Block n=52 participants at risk 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.	IV Analgesia-Fentanyl n=52 participants at risk 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.
Vascular disorders Hypotension	0.00% 0/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.	5.8% 3/52 • Number of events 3 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.

Other adverse events

Other adverse events
Measure	Femoral Nerve Block n=52 participants at risk 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.	IV Analgesia-Fentanyl n=52 participants at risk 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.
Nervous system disorders Headache	0.00% 0/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.	9.6% 5/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.
Nervous system disorders Dizziness	0.00% 0/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.	15.4% 8/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.
Gastrointestinal disorders Nausea	0.00% 0/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.	23.1% 12/52 • throughout the procedure and during the subsequent four-hour period Adverse events (such as hypotension, nausea, headache, and dizziness) were recorded throughout the procedure and during the subsequent four-hour period.

Additional Information

Dr. Emre Kudu

Marmara University School of Medicine

Phone: +902166254545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place