Clincosm LogoSign in Get a demo

Randomized Controlled Trial for Exparel Hip Fracture

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT03289858
Collaborator
Orthopaedic Trauma Association (Other), University of Kentucky (Other)
55
Enrollment
2
Locations
2
Arms
16.7
Actual Duration (Months)
27.5
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, randomized study looking at the effect that a long-acting local anesthetic has on pain control in patients having surgery for hip fractures. The investigators are conducting the study to see if that reduces the amount of pain medicine needed after surgery, and if it reduces other medical complications after surgery.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Osteoporotic fragility fractures of the hip are common in the geriatric population, are increasing in frequency, and represent a growing social and economic burden. Pain control after surgical treatment is an area of growing interest, as improvement in post-injury pain is often an important indication for surgical treatment of hip fractures.

Typically a mainstay of post-operative pain control, the use of opiates has come under increasing scrutiny, as it has been shown to be associated with delirium, respiratory depression, and even may even lead to addiction or abuse in the medically frail geriatric population. These concerns have led to efforts to minimize the use of post-operative opiates in hip fracture patients. In that context, a treatment that could reduce the necessity of post-op narcotics while still improving pain control would be potentially valuable.

There has been growing interest in the use of long-acting local anesthetics for improving pain control in orthopaedics, particularly in the elective total joint arthroplasty population. Studies have shown that arthroplasty patients receiving long-acting local anesthetics have decreased opiate requirements, reduced length of stay, and lower costs. Although well-demonstrated in the elective arthroplasty population, the effects of long-acting local anesthetics have yet to be demonstrated in the hip fracture population. Given that these fractures frequently occur in medically frail patients with multiple comorbidities, in whom post-operative confusion and delirium are relatively common, there is the potential for treatments that decrease opiate requirements to demonstrate substantial medical and economic benefits.

Exparel (liposomal bupivacaine) and long-acting local anesthetics have been used extensively in hip replacement surgery and have not been shown to be associated with any increased risks. In the case of patients with displaced femoral neck fractures treated with arthroplasty, the surgical techniques are identical to those being used in this study. Exparel has also been used in trauma surgery as well as foot and ankle surgery without any increased described risks, although its use explicitly in hip fractures has not been published. However, the PI has trained in other medical centers where Exparel is routinely used in hip fracture patients without any identified increased risks or complications, but there is a paucity of data on this subject, which is the rationale for this study.

The investigators hypothesize that in patients with osteoporotic fragility fractures of the hip, patients receiving intraoperative long-acting local anesthetics will have decreased pain and decreased post-operative opiate requirements, leading to less delirium and decreased hospital resource utilization during their index hospitalization.

The goal is to conduct a multi-center prospective randomized control trial to determine if liposomal bupivacaine is superior to standard of care by addressing the below separate but related aims:

  1. Determine the effectiveness of Exparel to reduce narcotic requirements and pain post operatively after hip fracture treatment. Excess narcotic use in the elderly population is associated with a host of complications often magnified by polypharmacy, including in hospital delirium, increased length of stay, nausea, constipation, urinary retention, respiratory depression and others. Decreasing narcotic usage in this group of patients following hip fracture can possibly reduce such complications. Patients will receive standard of care medical treatment and be randomized to intra-operative Exparel vs. placebo injections. Opioid requirements, complications, pain score, and length of stay will be assessed in the post-operative period. Hypothesis: The investigators hypothesize that total morphine requirements and pain scores will be decreased in this group following the administration of exparel in the geriatric hip fracture fracture population.

  2. Determine the effectiveness of Exparel to reduce delirium in post-operative hip fracture patients. In hospital delirium in elderly patients is associated with poor outcomes, including prolonged length of stay, poor participation in rehabilitation, and falls. Use of a locally administered liposomal bupivacaine could decrease the need for additional medications for pain control in addition to decreased mental stress for patients in this unfamiliar situation, thus resulting in decreased episodes of delirium. The investigators will assess delirium utilizing Confusion Assessment Method (CAM) scores in the post-operative period at regularly scheduled intervals and compare average scores between the treatment / standard of care group. Hypothesis: The investigators hypothesize that total episodes of delirium will be decreased in the liposomal bupivacaine group.

  3. Determine if Exparel is cost-effective in hip fracture patients. The costs associated with increased narcotic usage, prolonged stay, resources, and complications can be significant. The use of liposomal bupivacaine may lead to decreased resource utilization to care for hip fractures. The investigators will conduct an economic analysis evaluating total inpatient hospitalization costs including costs associated with length of stay, medication requirements, and resources associated with consultations and diagnostic evaluations. These costs will be compared against the cost of Exparel administration to evaluate the net cost effect of the intervention. Hypothesis: The investigators hypothesize that the net cost of inpatient care will be decreased when compared to standard of care.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does the Use of Liposomal Bupivacaine Decrease Narcotic Requirements in Geriatric Hip Fractures? A Randomized, Double Blinded Control Trial
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jan 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exparel (Liposomal Bupivacaine)

Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia."

Drug: Exparel
Subcutaneous injection at conclusion of surgical fixation of hip fracture
Other Names:
  • Liposomal Bupivacaine

    		•
    Placebo Comparator: Saline Control

    Saline Solution (Sodium Chloride)

    Drug: Sodium Chloride
    Saline Injection
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opiate Requirements [72 hours]

      Morphine meq given

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 55 or older

    • Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty

    • Able to consent

    • Isolated injury

    Exclusion Criteria:

    • OTA/AO 31B1 (Impacted/slightly displaced)

    • Baseline dementia or cognitive deficit

    • Inability to consent

    • Chronic Opioid use

    • End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.

    • End stage renal disease as defined by patients requiring hemodialysis at least twice weekly

    • Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture, spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or diagnosed concussion

    • Allergy to amide-type local anesthetics

    • Prisoners (unlikely to be accessible for follow-up)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40536
    2 UMass Memorial Medical Center Worcester Massachusetts United States 01655

    Sponsors and Collaborators

    • University of Massachusetts, Worcester
    • Orthopaedic Trauma Association
    • University of Kentucky

    Investigators

    • Principal Investigator: Eric Swart, MD, UMASS Memorial Medical Center
    • Principal Investigator: Paul Matuszewski, MD, University of Kentucky

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Eric Swart, Eric F. Swart, MD, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT03289858
    Other Study ID Numbers:
    • H00013594
    First Posted:
    Sep 21, 2017
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Fractures, Bone
    Hip Fractures
    Bupivacaine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Exparel (Liposomal Bupivacaine) Saline Control
    Arm/Group Description Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
    Period Title: Overall Study
    STARTED 27 28
    COMPLETED 25 28
    NOT COMPLETED 2 0

    Baseline Characteristics

    Arm/Group Title Exparel (Liposomal Bupivacaine) Saline Control Total
    Arm/Group Description Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection Total of all reporting groups
    Overall Participants 27 28 55
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    76
    (8.6)
    77
    (9.2)
    76
    (8.8)
    Sex: Female, Male (Count of Participants)
    Female
    20
    74.1%
    20
    71.4%
    40
    72.7%
    Male
    7
    25.9%
    8
    28.6%
    15
    27.3%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    27
    100%
    28
    100%
    55
    100%

    Outcome Measures

    1. Primary Outcome
    Title Opiate Requirements
    Description Morphine meq given
    Time Frame 72 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Exparel (Liposomal Bupivacaine) Saline Control
    Arm/Group Description Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
    Measure Participants 25 28
    Mean (95% Confidence Interval) [Morphine mEq]
    52.5
    65.39

    Adverse Events

    Time Frame 3 months
    Adverse Event Reporting Description Patients were actively screened for a list of complications daily during their admission and at their 2 and 6 week follow up appointments.
    Arm/Group Title Exparel (Liposomal Bupivacaine) Saline Control
    Arm/Group Description Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
    All Cause Mortality
    Exparel (Liposomal Bupivacaine) Saline Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/28 (0%)
    Serious Adverse Events
    Exparel (Liposomal Bupivacaine) Saline Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 1/28 (3.6%)
    Skin and subcutaneous tissue disorders
    Infection 0/27 (0%) 1/28 (3.6%)
    Other (Not Including Serious) Adverse Events
    Exparel (Liposomal Bupivacaine) Saline Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/28 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Eric Swart
    Organization University of Massachusetts, Worcester
    Phone 503-880-7125
    Email eric.swart@umassmemorial.org
    Responsible Party:
    Eric Swart, Eric F. Swart, MD, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT03289858
    Other Study ID Numbers:
    • H00013594
    First Posted:
    Sep 21, 2017
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021