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Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

Evaluation of the Efficacy of Exparel Delivered Into the Hip Capsule During Hemiarthroplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502018
Acronym
HEAT
Enrollment
50
Registered
2018-04-18
Start date
2018-03-01
Completion date
2023-08-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracapsular Fracture of Femur, Femoral Neck Fractures, Hip Hemiarthroplasty

Keywords

Exparel, Bupivacaine, Intracapsular Fracture of the Femur, Femoral Neck Fracture, Hip Hemiarthroplasty

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).

Interventions

A long-acting liposomal bupivacaine

DRUGSaline

Saline injection used as control

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative Pain4hrs after surgeryPrimary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Secondary

MeasureTime frameDescription
Time to Ambulation24 and 48 hours after surgeryMeasure of time to ambulation with physical therapy
Postoperative Total Morphine Equivalent48 hours after surgeryTotal 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
Delirium Scale Measurements24 and 48 hours after surgeryAssessment of post-operative delirium based on Short Confusion Assessment Method
Length of Stay7 days from day of admissionTotal days until discharge from hospital

Countries

United States

Participant flow

Participants by arm

ArmCount
Saline
This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control
24
Bupivacaine Liposome
This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
25
Total49

Baseline characteristics

CharacteristicSalineBupivacaine LiposomeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
24 Participants25 Participants49 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants3 Participants
Race (NIH/OMB)
White
16 Participants23 Participants39 Participants
Region of Enrollment
United States
24 participants25 participants49 participants
Sex: Female, Male
Female
20 Participants18 Participants38 Participants
Sex: Female, Male
Male
4 Participants7 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 250 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Post-operative Pain

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

Time frame: 4hrs after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePost-operative Pain3.29 score on a scaleStandard Deviation 2.66
Bupivacaine LiposomePost-operative Pain2.64 score on a scaleStandard Deviation 2.27
Primary

Post-operative Pain

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

Time frame: 8hrs after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePost-operative Pain3.04 score on a scaleStandard Deviation 1.64
Bupivacaine LiposomePost-operative Pain2.12 score on a scaleStandard Deviation 1.79
Primary

Post-operative Pain

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

Time frame: 12hrs after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePost-operative Pain2.42 score on a scaleStandard Deviation 2.19
Bupivacaine LiposomePost-operative Pain2.08 score on a scaleStandard Deviation 2.72
Primary

Post-operative Pain

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

Time frame: 24hrs after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePost-operative Pain2.58 score on a scaleStandard Deviation 2.86
Bupivacaine LiposomePost-operative Pain2.00 score on a scaleStandard Deviation 2.48
Primary

Post-operative Pain

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

Time frame: 48hrs after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePost-operative Pain2.71 score on a scaleStandard Deviation 3.1
Bupivacaine LiposomePost-operative Pain2.04 score on a scaleStandard Deviation 2.69
Secondary

Delirium Scale Measurements

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

Time frame: 24 and 48 hours after surgery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
SalineDelirium Scale MeasurementsAt 24 Hours0 Participants
SalineDelirium Scale MeasurementsAt 48 Hours0 Participants
SalineDelirium Scale MeasurementsNo Delirium24 Participants
Bupivacaine LiposomeDelirium Scale MeasurementsAt 24 Hours1 Participants
Bupivacaine LiposomeDelirium Scale MeasurementsAt 48 Hours0 Participants
Bupivacaine LiposomeDelirium Scale MeasurementsNo Delirium24 Participants
Secondary

Length of Stay

Total days until discharge from hospital

Time frame: 7 days from day of admission

ArmMeasureValue (MEAN)Dispersion
SalineLength of Stay3.88 DaysStandard Deviation 2.13
Bupivacaine LiposomeLength of Stay3.92 DaysStandard Deviation 1.44
Secondary

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

Time frame: 48 hours after surgery

ArmMeasureValue (MEAN)Dispersion
SalinePostoperative Total Morphine Equivalent9.98 Morphine EquivalentStandard Deviation 10.638927
Bupivacaine LiposomePostoperative Total Morphine Equivalent12.09 Morphine EquivalentStandard Deviation 9.65
Secondary

Time to Ambulation

Measure of time to ambulation with physical therapy

Time frame: 24 and 48 hours after surgery

ArmMeasureValue (MEAN)Dispersion
SalineTime to Ambulation1.44 DaysStandard Deviation 0.82
Bupivacaine LiposomeTime to Ambulation1.12 DaysStandard Deviation 0.53

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026