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
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Femoral Neck Fractures
Hip Fractures
Interventions: Drug: Femoral nerve block: 25 mL of 0.5% bupivacaine
Drug: Placebo: 3cc of 0.9% Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult ER patients at Rhode Island Hospital were recruited during the course of their clinical care between January 2010 and January 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were approached after being triaged into the ER system and arrival in a private room but before receiving pain medication for hip fracture. Patients who declined did so because their pain was not severe enough, or they chose not to participate or could not consent, or they were sensitive to morphine (a required component of the study).

Reporting Groups
  Description
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.

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.

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.

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


Participant Flow:   Overall Study
    Femoral Nerve Block (FNB)     Standard Care (SC)  
STARTED     19     19  
COMPLETED     18     18  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
It was determined that a sample size of 17 in each arm would provide 80% power to detect at least a 33% PID. Sample size was inflated by 10% to account for attrition, missing data, and protocol violations, for a total of 19 subjects in each arm.

Reporting Groups
  Description
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.

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.

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.

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

Total Total of all reporting groups

Baseline Measures
    Femoral Nerve Block (FNB)     Standard Care (SC)     Total  
Number of Participants  
[units: participants]
  19     19     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     10     10     20  
Gender  
[units: participants]
     
Female     11     13     24  
Male     8     6     14  



  Outcome Measures

1.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Francesca Beaudoin MD, MS
Organization: Dept of Emergency Medicine, Rhode Island Hospital
phone: 401-444-2577
e-mail: fbeaudoin@lifespan.org


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