Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial

This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Study Overview

• Status: Terminated
• Conditions: Femoral Fractures
• Intervention / Treatment: Drug: Liposomal Bupivacaine; Drug: Ropivacaine HCL

Detailed Description

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.

The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Med Center- Trauma and Acute Care Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age ≥18 years ≤ 70 years
2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.

Exclusion Criteria:

1. >10 hours since presentation to the emergency department
2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
3. Central or peripheral neurologic deficit on presentation
4. Concern or compartment syndrome
5. Associated additional long bone fractures
6. End stage liver failure
7. Renal failure requiring dialysis
8. Pregnancy or breast feeding
9. Prisoners
10. Coagulopathy with INR >1.5
11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
13. Adults unable to consent
14. Pediatric patients <18 years old
15. Patients exhibiting signs of shock upon admission, HR >120 or SBP <100 mmHg.
16. History of allergic reaction to local anesthetics
17. Administration of any other local anesthetic in the 2 hours prior to the study enrollment.
18. Distal femur fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Liposomal Bupivacaine; In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered	Drug: Liposomal Bupivacaine; A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine; Other Names: Exparel®
PLACEBO_COMPARATOR: Ropivacaine HCL; In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered	Drug: Ropivacaine HCL; Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.; Other Names: Naropin (trade name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Requirements	Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents	Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcomes	Total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay	Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.

Collaborators and Investigators

• Sponsor: Ian Elliott Brown
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ian Brown, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (ESTIMATE): February 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: femur fracture, hip fracture, exparel, liposomal bupivacaine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 782382; D6.715L15J91110 (OTHER_GRANT: Defense Health Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No