AzTrials
AzTrials

PainPhase 3NCT00749489

Improving Pain and Function in Hip Fracture

A Phase 3 study testing Femoral Nerve Block in people with Pain and Hip Fractures, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare two different methods of treating pain after a hip fracture. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Pain, Hip Fractures
What is being tested?
Femoral Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
3 sitesUnited States
Study dates
Nov 2008to May 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients 60 years of age and over that present to the MSMC ED from 8:00 to 20:00 with a radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular) will be screened for study eligibility.

Who cannot join

  • History of advanced dementia
  • Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
  • Patients transferred from another hospital
  • Patients with cirrhosis or liver failure.
  • The investigators exclude patients with advanced dementia because the investigators will require patients to self-report their pain intensity.
  • The investigators exclude these categories of hip fracture because they represent patients with atypical or often problematic clinical circumstances.
  • The investigators exclude patients under age 60 because our focus is on treatment of pain in older adults. Younger adults (less than age 60) typically present with fractures of different cause (severe and multiple trauma), are less sensitive to the side effects and complications of opioid therapy, are less likely to have delayed or prolonged functional recovery, and are less sensitive to the adverse and sometimes permanent effects of prolonged bed rest (i.e., from pain) on function.
  • The investigators exclude patients with hepatic dysfunction because the intervention protocol includes administration of acetaminophen which can provoke liver failure in patients with advanced liver disease.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Beth Israel

    New York, New York, 10003

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Maimonides Medical Center

    New York, New York, 11219

Other trials in United States

About this study

The purpose of this study is to compare two different methods of treating pain after a hip fracture.

Read the detailed description

This project examines the efficacy and effects of 2 regional anesthesia techniques, femoral nerve blocks (FNB) and fascia iliaca blocks (FIB), on the treatment of peri-operative acute hip (femoral neck, intertrochanteric) fracture pain. Patients age 60 years and over presenting to two New York City emergency departments with hip fracture will be randomized to receive the intervention or usual care. The intervention includes single injection FNB in the ED followed by insertion of a continuous FIB catheter within 24 hours of the single injection FNB plus "as needed" non-opioid/opioid analgesia. Usual care patients will receive conventional therapy with regularly scheduled intravenous or oral opioids plus "as needed" non/opioids/opioids. We will examine the impact of the intervention on patients' self reported pain intensity; systemic opioid requirements; post-operative function; incidence of delirium, treatment related side effects; and hospital length of stay and participation in physical therapy.

Conditions
Pain, Hip Fractures
Being tested
Femoral Nerve Block
Keywords
Pain, Hip Fractures, Femoral Fractures, Analgesics, Opioid, Nerve Block, Geriatric, Nerve Stimulation
Medical subject headings
Pain, Hip Fractures, Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Femoral Nerve BlockProcedure or surgery

    Patients assigned to the intervention group will have a femoral nerve block administered by the attending emergency department physician. Twenty-four hours after the femoral nerve block or at the time of surgery, an anesthesiologist will insert a continuous fascia iliaca block. Both procedures (femoral nerve block and fascia iliaca blocks) are standard anesthetic techniques that are used in orthopedic procedures but their efficacy as compared to standard opioid therapy has not been evaluated in controlled clinical trials in hip fracture. The medications that will be used in each procedure are as follows: 1) femoral nerve block: 0.5% bupivacaine with 1:300,000 epinephrine; 2) fascia iliaca block: 0.2% ropivacaine will be infused at 5ml/hr.

Study groups in NCT00749489
Study groupRoleWhat they receive
Femoral Nerve BlockExperimentalIntervention patients will have a continuous fascia iliaca blocks placed by a regional anesthesiologist 24 hours after the initial single injection femoral nerve block or at the time of surgery.
Receives: Procedure: Femoral Nerve Block
No InterventionNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain; 11-point Numeric Rating Scale

    Measured: three times daily for pain for the duration of hospital stay (average stay is 4 days)

Secondary outcomes (1)

  1. Delirium; Confusion Assessment Method (CAM).

    Measured: three times daily for pain for the duration of hospital stay (average stay is 4 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749489
Sponsor's protocol ID
GCO 06-0721
Other IDs
AG030141-01 A1
Status last verified
Jun 2014
First submitted
8 Sep 2008
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33238043

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Femoral Nerve Block in people with Pain and Hip Fractures, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain; 11-point Numeric Rating Scale (time frame: three times daily for pain for the duration of hospital stay (average stay is 4 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in