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

Primary Purpose

Femoral Fractures

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Liposomal Bupivacaine

Ropivacaine HCL

About this trial

This is an interventional treatment trial for Femoral Fractures focused on measuring femur fracture, hip fracture, exparel, liposomal bupivacaine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of California Davis Med Center- Trauma and Acute Care Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Liposomal Bupivacaine

Ropivacaine HCL

Arm Description

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered

In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered

Outcomes

Primary Outcome Measures

Opioid Requirements

Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02679560

First Posted

February 8, 2016

Last Updated

February 3, 2021

Sponsor

Ian Elliott Brown

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT02679560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ian Elliott Brown

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Fractures

Keywords

femur fracture, hip fracture, exparel, liposomal bupivacaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposomal Bupivacaine

Arm Type

Active Comparator

Arm Description

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered

Arm Title

Ropivacaine HCL

Arm Type

Placebo Comparator

Arm Description

In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered

Intervention Type

Drug

Intervention Name(s)

Liposomal Bupivacaine

Other Intervention Name(s)

Exparel®

Intervention Description

A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine

Intervention Type

Drug

Intervention Name(s)

Ropivacaine HCL

Other Intervention Name(s)

Naropin (trade name)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Opioid Requirements

Description

Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents

Time Frame

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 Measure Information:

Title

Patient Outcomes

Description

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

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age ≥18 years ≤ 70 years Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident. Exclusion Criteria: >10 hours since presentation to the emergency department History of seizure disorder, recent seizure or a document intra-cranial hemorrhage. Central or peripheral neurologic deficit on presentation Concern or compartment syndrome Associated additional long bone fractures End stage liver failure Renal failure requiring dialysis Pregnancy or breast feeding Prisoners Coagulopathy with INR >1.5 Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally Adults unable to consent Pediatric patients <18 years old Patients exhibiting signs of shock upon admission, HR >120 or SBP <100 mmHg. History of allergic reaction to local anesthetics Administration of any other local anesthetic in the 2 hours prior to the study enrollment. Distal femur fractures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Brown, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Davis Med Center- Trauma and Acute Care Surgery

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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