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

NCT ID: NCT02679560

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-11-01

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

Conditions

Femoral Fractures

Study Design

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

Study Groups

Liposomal Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type: DRUG

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

Ropivacaine HCL

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

Group Type: PLACEBO_COMPARATOR

Ropivacaine HCL

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Exparel®; Naropin (trade name)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Ian Elliott Brown

OTHER

Sponsor Role: lead

Responsible Party

Ian Elliott Brown

Assistant Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ian Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D6.715L15J91110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

782382

Identifier Type: -

Identifier Source: org_study_id