Femoral Fractures
Conditions
Keywords
femur fracture, hip fracture, exparel, liposomal bupivacaine
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
Interventions
DRUGLiposomal 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
DRUGRopivacaine 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.
Sponsors
United States Department of Defense
Ian Elliott Brown
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements | 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. | Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Outcomes | 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. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered
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 | 1 |
| Ropivacaine HCL In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered
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. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Ropivacaine HCL | Total | Liposomal Bupivacaine |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 14 | 45 years STANDARD_DEVIATION 7 | 57 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 1 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Opioid Requirements
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.
Population: There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.
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
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.
Population: There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.