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Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients

Ultrasound Guided Femoral (3 in 1) Nerve Block Versus Ultrasound Guided Fascia Iliacus Compartment Block Versus Standard Treatment for Pain Control in Patients With Hip Fractures in the Emergency Department

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01904071
Enrollment
64
Registered
2013-07-22
Start date
2008-10-31
Completion date
2010-08-31
Last updated
2018-06-06

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

Conditions

Hip Fracture

Keywords

Hip Fracture, Ultrasound, Nerve Block

Brief summary

Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED) with intravenous opiates. However, this class of medications may cause deleterious side effects. An alternative analgesic approach involves regional anesthesia. The investigators attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be safely performed in an ED setting, (2) whether UPNBs would be more effective than standard treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain relief. A convenience sample of patients with an isolated HFx and a pain score \> 5/10 were enrolled and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB), (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated their pain from 0 (no pain) to 10 (extreme pain).

Detailed description

Hip fracture (HFx) is a painful orthopedic emergency that commonly presents to the Emergency Department (ED). There are approximately 320,000 HFx diagnosed annually in the United States, with this number expected to increase as the population ages. It has previously been shown that patients with pain from HFx are undermedicated while in the ED, particularly in overcrowded facilities. Current treatment for ED patients who are experiencing pain from acute HFx is often with intravenous morphine sulfate (IVMS). Morphine can have many undesirable side effects, but of particular concern are delirium, hypotension and respiratory depression. These complications may be accentuated in elderly patients and may necessitate increased patient monitoring and greater utilization of limited ED resources.An alternative to systemic opioid analgesia involves peripheral nerve blockade. Anesthesiologists frequently perform nerve blocks in the peri-operative and post-operative period to control pain in patients undergoing hip surgery. Traditionally, nerve stimulators were used to place the nerve block. However, ultrasonography is being used with increasing frequency to facilitate placement of these peripheral nerve blocks. As Emergency Physicians (EP) become more facile with the use of bedside sonography, ultrasound guided peripheral nerve blockade for HFx may be ideally suited for the ED environment, where one injection could control pain for many hours. The 3-in-1 femoral nerve block (FNB), in which anesthetic is injected adjacent to the femoral nerve but also affects the lateral femoral cutaneous and the obturator nerves, has been shown to be as effective as morphine for pain control of HFx in the ED. Sonographic guidance has been shown to increase the success rate of this block, decrease the time to analgesia, decrease the amount of local anesthetic needed to achieve adequate regional anesthesia, and decrease the incidence of inadvertent intravascular injection. To date, there has been limited research describing the utilization of ultrasound guided femoral nerve blocks in an ED setting. Beaudoin et al. performed a feasibility study demonstrating that EP could effectively perform ultrasound guided femoral nerve blocks. Reid et al. found a significantly decreased time to complete analgesia when using sonographic guidance compared to an anatomic landmark technique. In this later study, anesthesia was assessed by checking skin sensation. Neither of these studies utilized a 3-in-1 nerve block, which may provide greater pain relief for patients with HFx. The fascia iliaca compartment block (FIB) is also effective for treating pain due to HFx. It has been shown in the pediatric anesthesia and pediatric emergency medicine literature that it provides adequate analgesia, and may provide more effective analgesia than the FNB for femur fractures in children. Most of the studies describe the FIB being performed using a technique based on anatomic landmarks. One recent study described ultrasound guidance of the FIB (UFIB) increasing the efficacy of the sensory blockade (12). UFIB has not previously been studied in the ED setting. We attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNB) could be safely performed in an ED setting, (2) whether UPNB would be more effective than standard treatment in controlling pain from HFx in which a 2.5 unit decrease in pain scores was considered clinically significant, and (3) which of two UPNB was superior for pain relief.

Interventions

PROCEDUREUFNB (Ultrasound guided femoral nerve block)

Ultrasound Guided Femoral Nerve Block

PROCEDUREUFIB (Ultrasound Guided Fascia Iliaca Compartment Block)
DRUGIVMS (IV Morphine)

Intravenous Morphine

Sponsors

Emergency Medicine Foundation
CollaboratorOTHER
Antonios Likourezos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

1. English speaking patients 2. ≥18 years of age 3. radiographic evidence of hip fracture 4. Patients must be awake, alert and oriented to time, place and person. 5. pain score of ≥ 5 in 10 point scale.

Exclusion criteria

1. cognitive deficits 2. allergic to amide-type local anesthetic or morphine 3. more injuries than just hip fracture.

Design outcomes

Primary

MeasureTime frameDescription
Pain Score at 30 Minutes30 minutesPain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Secondary

MeasureTime frameDescription
Pain Score at 60 Minutes60 minutesPain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Other

MeasureTime frameDescription
Pain Score at 120 Minutes120 minutesPain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Pain Score at 240 Minutes240 minutesPain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Pain Score at 480 Minutes480 minutesPain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Countries

United States

Participant flow

Participants by arm

ArmCount
UFNB
Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)
24
UFIB
Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)
20
IVMS
IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
20
Total64

Baseline characteristics

CharacteristicUFNBUFIBIVMSTotal
Age, Continuous82 years
STANDARD_DEVIATION 9.96
82 years
STANDARD_DEVIATION 7.74
85 years
STANDARD_DEVIATION 7.91
83 years
STANDARD_DEVIATION 8.64
Pain Score at Triage5.17 units on a scale
STANDARD_DEVIATION 3.29
5.50 units on a scale
STANDARD_DEVIATION 3.99
6.98 units on a scale
STANDARD_DEVIATION 1.87
5.84 units on a scale
STANDARD_DEVIATION 3.23
Region of Enrollment
United States
24 participants20 participants20 participants64 participants
Sex: Female, Male
Female
17 Participants11 Participants13 Participants41 Participants
Sex: Female, Male
Male
7 Participants9 Participants7 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 240 / 200 / 20
serious
Total, serious adverse events
0 / 240 / 200 / 20

Outcome results

Primary

Pain Score at 30 Minutes

Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Time frame: 30 minutes

ArmMeasureValue (MEAN)Dispersion
UFNBPain Score at 30 Minutes1.94 units on a scaleStandard Deviation 2.43
UFIBPain Score at 30 Minutes2.05 units on a scaleStandard Deviation 2.61
IVMSPain Score at 30 Minutes5.13 units on a scaleStandard Deviation 2.7
p-value: <0.0001ANOVA
Secondary

Pain Score at 60 Minutes

Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Time frame: 60 minutes

ArmMeasureValue (MEAN)Dispersion
UFNBPain Score at 60 Minutes2.58 units on a scaleStandard Deviation 3.06
UFIBPain Score at 60 Minutes1.90 units on a scaleStandard Deviation 2.38
IVMSPain Score at 60 Minutes4.40 units on a scaleStandard Deviation 2.92
p-value: <0.05ANOVA
Other Pre-specified

Pain Score at 120 Minutes

Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Time frame: 120 minutes

Population: Pain score was not obtained for one patient in the IVMS group at 120 minutes.

ArmMeasureValue (MEAN)Dispersion
UFNBPain Score at 120 Minutes2.65 units on a scaleStandard Deviation 2.49
UFIBPain Score at 120 Minutes1.30 units on a scaleStandard Deviation 1.89
IVMSPain Score at 120 Minutes4.00 units on a scaleStandard Deviation 2.98
p-value: <0.005ANOVA
Other Pre-specified

Pain Score at 240 Minutes

Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Time frame: 240 minutes

Population: Pain score was not obtained for one patient in the UFNB group at 240 minutes

ArmMeasureValue (MEAN)Dispersion
UFNBPain Score at 240 Minutes3.15 units on a scaleStandard Deviation 2.7
UFIBPain Score at 240 Minutes1.72 units on a scaleStandard Deviation 1.98
IVMSPain Score at 240 Minutes4.83 units on a scaleStandard Deviation 2.58
p-value: <0.001ANOVA
Other Pre-specified

Pain Score at 480 Minutes

Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Time frame: 480 minutes

Population: Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes

ArmMeasureValue (MEAN)Dispersion
UFNBPain Score at 480 Minutes3.20 units on a scaleStandard Deviation 2.28
UFIBPain Score at 480 Minutes2.35 units on a scaleStandard Deviation 3.07
IVMSPain Score at 480 Minutes3.74 units on a scaleStandard Deviation 2.89
p-value: 0.342ANOVA

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