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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01701414
First received: September 27, 2012
Last updated: February 7, 2014
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Femoral Neck Fractures
Hip Fractures
Drug: Femoral nerve block: 25 mL of 0.5% bupivacaine
Drug: Placebo: 3cc of 0.9% Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Femoral Nerve Blocks in Elderly Patients With Hip Fractures: a Randomized Controlled Clinical Study

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Number of Participants Reporting at Least One NRS Rating [ Time Frame: 30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating. ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Standard Care (SC)
The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.
Drug: Placebo: 3cc of 0.9% Normal Saline
1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice
Experimental: Femoral Nerve Block (FNB)
Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name "3-in-1 femoral block" is often used), providing maximum analgesia to the hip.
Drug: Femoral nerve block: 25 mL of 0.5% bupivacaine
25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.

Detailed Description:

Hip fractures are a significant cause of morbidity and mortality in the elderly. In the acute setting, safe and effective pain control is of the utmost importance. At present, this is typically achieved with the use of parenteral opioids. However in older individuals, who often have other medical comorbidities, the use of narcotics for pain control must be balanced with their potentially deleterious consequences: namely respiratory depression, hypotension, and mental confusion. Both poor pain control and the use of opioid medications have been associated with acute confusional states in the elderly. 1,2 Regional anesthesia can possibly provide adjunctive or even alternative pain control that is both safe and effective.Femoral nerve blocks, using local anesthetics, have been described as a method to reduce pain and the requirement for systemic analgesia, specifically opioids. Prior research has demonstrated feasibility and effective pain control of the femoral nerve block in the ED setting. Bedside ultrasound (US) can be used to precisely visualize the femoral neurovascular anatomy when performing a femoral nerve block and has distinct advantages when performing this procedure in the ED setting.

Study Objectives The primary aim of this study is to determine the relative effectiveness of ultrasound guided femoral nerve blocks in older adult patients with hip fractures in the emergency department as compared with parenteral narcotics alone. A secondary aim of this study is to determine if femoral nerve blocks reduce both the use of parenteral narcotics and the incidence adverse effects associated with parenteral analgesia (delirium, hypotension, respiratory depression) in hip fracture patients both in the emergency department and during their hospital stay.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701414

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Otto Liebmann, MD Rhode Island Hospital
Principal Investigator: Francesca Beaudoin, MD, MS Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01701414     History of Changes
Other Study ID Numbers: 210423
Study First Received: September 27, 2012
Results First Received: May 29, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhode Island Hospital:
Femur
Hip
Fracture
Femoral neck
Femoral head

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014