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

Femoral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02679560
• Other study ID #: 782382
• Secondary ID: D6.715L15J91110
• Status: Terminated
• Phase: Phase 2
• Start date: October 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Femoral Fractures
• Fractures, Bone

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of California Davis Med Center- Trauma and Acute Care Surgery	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Ian Elliott Brown	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.