Trial Outcomes & Findings for Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients (NCT NCT01904071)
NCT ID: NCT01904071
Last Updated: 2018-06-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
30 minutes
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
20
|
|
Overall Study
COMPLETED
|
24
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients
Baseline characteristics by cohort
| Measure |
UFNB
n=24 Participants
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)
|
UFIB
n=20 Participants
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)
|
IVMS
n=20 Participants
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)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
82 years
STANDARD_DEVIATION 9.96 • n=99 Participants
|
82 years
STANDARD_DEVIATION 7.74 • n=107 Participants
|
85 years
STANDARD_DEVIATION 7.91 • n=206 Participants
|
83 years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
20 participants
n=107 Participants
|
20 participants
n=206 Participants
|
64 participants
n=7 Participants
|
|
Pain Score at Triage
|
5.17 units on a scale
STANDARD_DEVIATION 3.29 • n=99 Participants
|
5.50 units on a scale
STANDARD_DEVIATION 3.99 • n=107 Participants
|
6.98 units on a scale
STANDARD_DEVIATION 1.87 • n=206 Participants
|
5.84 units on a scale
STANDARD_DEVIATION 3.23 • n=7 Participants
|
PRIMARY outcome
Timeframe: 30 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
Outcome measures
| Measure |
UFNB
n=24 Participants
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)
|
UFIB
n=20 Participants
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)
|
IVMS
n=20 Participants
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)
|
|---|---|---|---|
|
Pain Score at 30 Minutes
|
1.94 units on a scale
Standard Deviation 2.43
|
2.05 units on a scale
Standard Deviation 2.61
|
5.13 units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 60 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
Outcome measures
| Measure |
UFNB
n=24 Participants
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)
|
UFIB
n=20 Participants
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)
|
IVMS
n=20 Participants
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)
|
|---|---|---|---|
|
Pain Score at 60 Minutes
|
2.58 units on a scale
Standard Deviation 3.06
|
1.90 units on a scale
Standard Deviation 2.38
|
4.40 units on a scale
Standard Deviation 2.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 minutesPopulation: Pain score was not obtained for one patient in the IVMS group 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
Outcome measures
| Measure |
UFNB
n=24 Participants
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)
|
UFIB
n=20 Participants
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)
|
IVMS
n=19 Participants
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)
|
|---|---|---|---|
|
Pain Score at 120 Minutes
|
2.65 units on a scale
Standard Deviation 2.49
|
1.30 units on a scale
Standard Deviation 1.89
|
4.00 units on a scale
Standard Deviation 2.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 240 minutesPopulation: Pain score was not obtained for one patient in the UFNB group 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
Outcome measures
| Measure |
UFNB
n=23 Participants
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)
|
UFIB
n=20 Participants
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)
|
IVMS
n=20 Participants
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)
|
|---|---|---|---|
|
Pain Score at 240 Minutes
|
3.15 units on a scale
Standard Deviation 2.70
|
1.72 units on a scale
Standard Deviation 1.98
|
4.83 units on a scale
Standard Deviation 2.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 480 minutesPopulation: 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
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
Outcome measures
| Measure |
UFNB
n=20 Participants
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)
|
UFIB
n=17 Participants
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)
|
IVMS
n=17 Participants
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)
|
|---|---|---|---|
|
Pain Score at 480 Minutes
|
3.20 units on a scale
Standard Deviation 2.28
|
2.35 units on a scale
Standard Deviation 3.07
|
3.74 units on a scale
Standard Deviation 2.89
|
Adverse Events
UFNB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UFIB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IVMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eitan Dickman, Director of EM Ultrasound
Maimonides Medical Center
Phone: 718-283-6057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place