Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

NCT ID: NCT03502018

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2023-08-31

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).

Conditions

Intracapsular Fracture of Femur; Femoral Neck Fractures; Hip Hemiarthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Saline

This arm will receive Saline along with Bupivacaine

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline injection used as control

Bupivacaine liposome

This arm will receive Exparel along with Bupivacaine

Group Type: EXPERIMENTAL

Bupivacaine liposome

Intervention Type: DRUG

A long-acting liposomal bupivacaine

Interventions

Bupivacaine liposome

A long-acting liposomal bupivacaine

Intervention Type: DRUG

Saline

Saline injection used as control

Intervention Type: DRUG

Other Intervention Names

Exparel; No other names

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kevin Kang

Primary research investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Komlos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Kevin Kang, MD

Role: STUDY_DIRECTOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-10-01

Identifier Type: -

Identifier Source: org_study_id