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

NCT01701414 | Completed Phase 2 Results DMC

• 1 other identifier: 210423
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femoral Neck Fractures; Hip Fractures

Keywords

Femur; Hip; Fracture; Femoral neck; Femoral head

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting at Least One NRS Rating

  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.

  30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.

Study Arms (2)

Standard Care (SC)

SHAM COMPARATOR

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

Femoral Nerve Block (FNB)

EXPERIMENTAL

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

Interventions

Femoral nerve block: 25 mL of 0.5% bupivacaine DRUG

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.

Femoral Nerve Block (FNB)

Placebo: 3cc of 0.9% Normal Saline DRUG

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

Standard Care (SC)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Fractures, Bone

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Francesca Beaudoin MD, MS
• Organization: Dept of Emergency Medicine, Rhode Island Hospital

fbeaudoin@lifespan.org

401-444-2577

Study Officials

• Otto Liebmann, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Francesca Beaudoin, MD, MS

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 5, 2012
• Study Start: November 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 12, 2014
• Results First Posted: February 7, 2014

Record last verified: 2008-02

Locations

US (1)