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Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty (HEAT)

Primary Purpose

Intracapsular Fracture of Femur, Femoral Neck Fractures, Hip Hemiarthroplasty

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine liposome
Saline
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracapsular Fracture of Femur focused on measuring Exparel, Bupivacaine, Intracapsular Fracture of the Femur, Femoral Neck Fracture, Hip Hemiarthroplasty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Bupivacaine liposome

Arm Description

This arm will receive Saline along with Bupivacaine

This arm will receive Exparel along with Bupivacaine

Outcomes

Primary Outcome Measures

Post-operative pain
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Post-operative pain
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Post-operative pain
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Post-operative pain
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Post-operative pain
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.

Secondary Outcome Measures

Time to ambulation
Measure of time to ambulation with physical therapy
Postoperative total morphine equivalent
Total dose in milligrams of opiates measured in total morphine equivalents
Delirium scale measurements
Assessment of post-operative delirium based on Short Confusion Assessment Method
Length of stay
Total days until discharge from hospital
30-day readmission rates
Measuring the total number of re-admissions
Adverse events
Total number and description of adverse events

Full Information

First Posted
March 27, 2018
Last Updated
August 9, 2022
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03502018
Brief Title
Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty
Acronym
HEAT
Official Title
Evaluation of the Efficacy of Exparel Delivered Into the Hip Capsule During Hemiarthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center

4. Oversight

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracapsular Fracture of Femur, Femoral Neck Fractures, Hip Hemiarthroplasty
Keywords
Exparel, Bupivacaine, Intracapsular Fracture of the Femur, Femoral Neck Fracture, Hip Hemiarthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, Investigator(s), outcome assessors will all be blinded throughout the duration of the trial. Care providers pre- and post- op will be blinded as well, the operative team will not be blinded.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
This arm will receive Saline along with Bupivacaine
Arm Title
Bupivacaine liposome
Arm Type
Experimental
Arm Description
This arm will receive Exparel along with Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Other Intervention Name(s)
Exparel
Intervention Description
A long-acting liposomal bupivacaine
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
No other names
Intervention Description
Saline injection used as control
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Time Frame
4hrs after surgery
Title
Post-operative pain
Description
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Time Frame
8hrs after surgery
Title
Post-operative pain
Description
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Time Frame
12hrs after surgery
Title
Post-operative pain
Description
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Time Frame
24hrs after surgery
Title
Post-operative pain
Description
Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores.
Time Frame
48hrs after surgery
Secondary Outcome Measure Information:
Title
Time to ambulation
Description
Measure of time to ambulation with physical therapy
Time Frame
24 and 48 hours after surgery
Title
Postoperative total morphine equivalent
Description
Total dose in milligrams of opiates measured in total morphine equivalents
Time Frame
12, 24, 36, 48 hours after surgery
Title
Delirium scale measurements
Description
Assessment of post-operative delirium based on Short Confusion Assessment Method
Time Frame
24 and 48 hours after surgery
Title
Length of stay
Description
Total days until discharge from hospital
Time Frame
7 days from day of admission
Title
30-day readmission rates
Description
Measuring the total number of re-admissions
Time Frame
30 days post discharge
Title
Adverse events
Description
Total number and description of adverse events
Time Frame
30 days post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Komlos, MD, PhD
Phone
718-283-8805
Email
dkomlos@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Kang, MD
Phone
718-283-8805
Email
kkang@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Komlos, MD, PhD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Kang, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Komlos, MD, PhD
Phone
718-283-8805
Email
dkomlos@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Kevin Kang, MD
Phone
718-283-8805
Email
kkang@maimonidesmed.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

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