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Intracapsular Fracture of FemurPhase 4HEATNCT03502018

Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

A Phase 4 study testing Bupivacaine liposome and Saline in people with Intracapsular Fracture of Femur and Femoral Neck Fractures, run by Maimonides Medical Center at 1 site in United States.

Completed

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

Official record
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Trial summary

This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior approach. Post-operative measures will be assessing pain, overall opiate use, delirium, time-to-ambulation and discharge status. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Bupivacaine liposome and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Mar 2018to 31 Aug 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Men and women sixty-five years of age and older with isolated intracapsular hip fractures undergoing hemi arthroplasty through a posterior approach with the ability to consent to the study.

Who cannot join

  • Under sixty-five years of age, extracapsular hip fracture, suffer from any form of cognitive compromise that leaves them unable to consent, or if they are treated with any surgical modality other than hip hemiarthroplasty.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Maimonides Medical Center

    Brooklyn, New York, 11219

Other trials in United States

About this study

Official title: Evaluation of the Efficacy of Exparel Delivered Into the Hip Capsule During Hemiarthroplasty

This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior approach. Post-operative measures will be assessing pain, overall opiate use, delirium, time-to-ambulation and discharge status.

Read the detailed description

Exparel is a long-acting and sustained release formulation of the local anesthetic, bupivacaine HCl. Recent studies have supported its efficacy following total joint arthroplasty, but little is known about Exparel's effectiveness in hip fracture patients. This investigation will study the effects of Exparel on postoperative pain following hip fracture surgery. This is a single center, randomized prospective double blinded study of 50 patients with hip fractures that will have intracapsular hip hemiarthroplasties and are 65 years or older. Twenty-five patients will be treated with intraoperative injections of Exparel. Current standard of care does not include any injection of pain medication during hip hemiarthroplasty. There is no 'standard treatment', but to use multimodal IV and oral analgesia. The control group consisting of the remaining 25 patients will receive 'standard treatment' (which is is multimodal IV and oral analgesia). Therefore, saline is the appropriate placebo and control injection for this study. There are minimal to no risks associated with the injection of saline into the soft tissues about the hip and will take <2 minutes to complete. The surgeries will be performed by five surgeons who will use their standard treatment or in the interventional group participants will relieve 20 cc of Exparel diluted with 40 ml 0.25% bupivacaine into the surrounding hip capsule: external rotators, gluteus medius, gluteus minimus, gluteus maximus, tensor fascia lata, vastus lateralis, and subcutaneous tissues.

Both the patient and the researcher following the patient postoperatively will be blinded. While the treating surgeon will be able to notice the difference between the placebo and Exparel, the outcomes outlined below will be recorded by the blinded Orthopaedic Research Resident who has no clinical responsibilities during his/her year of research and does not participate in operative procedures

There are two overall aims of this investigation. The first aim is to identify whether Exparel has an impact on postoperative pain and function following open treatment of hip fractures. The hypothesis is that injecting Exparel into the hip capsule and surrounding tissues will decrease narcotic use, and in turn decrease the risk of associated side effects including medically induced delirium, constipation, and decreased alertness. The second aim of the study is focused on examining whether increased pain control leads to better postoperative outcomes? When pain is better controlled via non-narcotic measures, overall patient comfort will improve while sparing cognitive function, decreasing time to ambulation, and accelerating progress with physical therapy. Quicker recovery times will then produce shorter hospital stays, which would yield better overall patient satisfaction and overall improved outcomesPatients with intracapsular hip fractures will undergo hip hemiarthroplasty using a bipolar prosthesis placed via a posterior approach. Primary outcome measures include postoperative visual analogue scale (VAS from 0-10) pain scores at 12, 24, 36, 48 hours after surgery, time to ambulation with physical therapy, need for postoperative total morphine equivalent, and delirium scale measurements. Secondary outcomes measures will compare length of stay, discharge disposition (home or skilled nursing facility), 30-day readmission rates, and adverse events leading to ICU care or reoperation. All patients in both groups will have access to breakthrough pain medication which will either be Immediate acting Oxycodone for moderate to severe pain (pain scale of 4-10, Acetaminophen or Toradol for mild to moderate pain (pain scale of 2-4).

Being tested
Bupivacaine liposome, Saline
Keywords
Exparel, Bupivacaine, Intracapsular Fracture of the Femur, Femoral Neck Fracture, Hip Hemiarthroplasty
Medical subject headings
Femoral Neck Fractures

What participants receive

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

  • Bupivacaine liposomeDrug

    Also called Exparel

    A long-acting liposomal bupivacaine

  • SalineDrug

    Also called No other names

    Saline injection used as control

Study groups in NCT03502018
Study groupRoleWhat they receive
SalinePlacebo comparatorThis arm will receive Saline along with Bupivacaine
Receives: Drug: Saline
Bupivacaine liposomeExperimentalThis arm will receive Exparel along with Bupivacaine
Receives: Drug: Bupivacaine liposome

What is being measured

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

  1. Post-operative Pain

    Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

    Measured: 4hrs after surgery

  2. Post-operative Pain

    Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

    Measured: 8hrs after surgery

  3. Post-operative Pain

    Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

    Measured: 12hrs after surgery

  4. Post-operative Pain

    Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

    Measured: 24hrs after surgery

  5. Post-operative Pain

    Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

    Measured: 48hrs after surgery

Secondary outcomes (4)
  1. Time to Ambulation

    Measure of time to ambulation with physical therapy

    Measured: 24 and 48 hours after surgery

  2. Postoperative Total Morphine Equivalent

    Total dose in milligrams of opiates measured in total morphine equivalents. This was measured by calculating the sum of total morphine equivalents administered within 48 hours postoperatively. Assessed at 12, 24, 36, 48 hours after surgery, total postoperative total morphine equivalents at 48 hours after surgery reported

    Measured: 48 hours after surgery

  3. Delirium Scale Measurements

    Assessment of post-operative delirium based on Short Confusion Assessment Method

    Measured: 24 and 48 hours after surgery

  4. Length of Stay

    Total days until discharge from hospital

    Measured: 7 days from day of admission

Timeline

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

  1. First posted18 Apr 2018
  2. Study start1 Mar 2018
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be a total of 50 patients enrolled in this randomized blinded prospective two arm study. The participants will be randomized into either the control or the EXPAREL treatment group, with 25 patients in each cohort.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03502018
Sponsor's protocol ID
2016-10-01
Acronym
HEAT
Status last verified
Oct 2023
First submitted
27 Mar 2018
Last updated
18 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine liposome and Saline in people with Intracapsular Fracture of Femur and Femoral Neck Fractures, run by Maimonides Medical Center at 1 site 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 1 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post-operative Pain (time frame: 4hrs after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Nov 2023.

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