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Phase 2 N=38 Randomized Triple-blind Treatment

Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures

Femoral Neck Fractures · Hip Fractures

Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants Reporting at Least One NRS Rating — 18; 18 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Femoral nerve block: 25 mL of 0.5% bupivacaine (Drug); Placebo: 3cc of 0.9% Normal Saline (Drug)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
Rhode Island Hospital
Primary completion
Feb 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting at Least One NRS Rating
18; 18

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.

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • Adults over age 55
  • Able to understand and give informed consent
  • Comfortable with the experimental protocol as outlined to them by the RA or physician investigator
  • Have radiologically confirmed hip fractures: femoral head, femoral neck intertrochanteric, or subtrochanteric femur fractures

Exclusion Criteria

  • Femoral artery grafts on the same side as the fracture
  • Extensive lower extremity trauma
  • Concurrent tibia-fibula fractures
  • Hypersensitivity to local anesthetics or morphine
  • Neurovascular injury
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01701414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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