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NCT01701414 · ClinicalTrials.gov registry record · Phase 2
Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures
A Phase 2 study of Hip Fractures and Femoral Neck Fractures, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01701414: Completed Phase 2 study of Hip Fractures and Femoral Neck Fractures, sponsored by Rhode Island Hospital.
NCT01701414 is a Phase 2 study of Hip Fractures and Femoral Neck Fractures that has completed, run by Rhode Island Hospital. The registered enrollment target is 38 participants, below the 619-participant average among 15 other Hip Fractures trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701414, a Phase 2 study of Hip Fractures and Femoral Neck Fractures, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if ultrasound guided femoral nerve blocks (localized anesthesia in the upper thigh) provide effective pain relief in adult patients with hip fractures in the emergency department and to determine if femoral nerve blocks can then be used to reduce the use of injected analgesia (anesthesia), therefore also causing fewer adverse effects associated with injected analgesia (such as bruising at the site of injection). 100 patients with hip fractures will be enrolled in the study. Patients will be randomly assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care (SC), which is injected analgesia alone. Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine (a local anesthetic of long duration) injected into the front of the thigh, at the site of pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so that no neither the patient or the treating physician knows to which group the patient was randomized. All blocks will be performed in the emergency department by an emergency physician trained in the use of ultrasound and ultrasound guided nerve blocks. Subjects will be asked to rate their pain on a numeric pain scale both before and after intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in the ER still). Additional data to be collected includes demographics, vital signs, and course of treatment resulting from the ED visit. Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly decrease or eliminate the need for narcotics.
Primary Outcome
Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.
Conditions Studied
Interventions
- DRUG Femoral nerve block: 25 mL of 0.5% bupivacaine
- DRUG Placebo: 3cc of 0.9% Normal Saline
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01701414 record still lists
NCT01701414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 619-participant average among 15 other Hip Fractures trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Hip Fractures appearing as the primary indexed condition, and to 2 interventions - of which Femoral nerve block: 25 mL of 0.5% bupivacaine is the first listed.
NCT01701414 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT01701414 about?
NCT01701414 is a clinical study titled "Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures". The purpose of this study is to determine if ultrasound guided femoral nerve blocks (localized anesthesia in the upper thigh) provide effective pain relief in adult patients with hip fractures in the emergency department and to determine if femoral nerve blocks can then be used to reduce the use of ...
What is the current status of trial NCT01701414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2008-11. Estimated completion is 2012-02.
What conditions does trial NCT01701414 study?
This clinical trial studies the following conditions: Hip Fractures, Femoral Neck Fractures.
What interventions are being tested in trial NCT01701414?
The interventions under investigation include: Femoral nerve block: 25 mL of 0.5% bupivacaine (DRUG), Placebo: 3cc of 0.9% Normal Saline (DRUG).
Who is sponsoring clinical trial NCT01701414?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01701414 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01701414's enrollment target sits among peer trials
38 15th of 15 higher than 1 of 15 other Hip Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hip Fractures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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