Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

NCT03502018 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016-10-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracapsular Fracture of Femur; Femoral Neck Fractures; Hip Hemiarthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (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

  4hrs after surgery

• Post-operative Pain

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

  8hrs after surgery

• Post-operative Pain

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

  12hrs after surgery

• Post-operative Pain

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

  24hrs after surgery

• Post-operative Pain

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

  48hrs after surgery

Secondary Outcomes (4)

• Time to Ambulation

  24 and 48 hours after surgery

• Postoperative Total Morphine Equivalent

  48 hours after surgery

• Delirium Scale Measurements

  24 and 48 hours after surgery

• Length of Stay

  7 days from day of admission

Study Arms (2)

Saline

PLACEBO COMPARATOR

This arm will receive Saline along with Bupivacaine

Drug: Saline

Bupivacaine liposome

EXPERIMENTAL

This arm will receive Exparel along with Bupivacaine

Drug: Bupivacaine liposome

Interventions

Bupivacaine liposome DRUG

A long-acting liposomal bupivacaine

Also known as: Exparel

Bupivacaine liposome

Saline DRUG

Saline injection used as control

Also known as: No other names

Saline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Kevin Kang
• Organization: Maimonides Medical Center

kkang@maimonidesmed.org

718-283-8805

Study Officials

• Daniel Komlos, MD, PhD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

• Kevin Kang, MD

  Maimonides Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary research investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 18, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Locations

US (1)