Trial Outcomes & Findings for Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures (NCT NCT02679560)
NCT ID: NCT02679560
Last Updated: 2021-02-21
Results Overview
Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
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.
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=1 Participants
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
|
Ropivacaine HCL
n=2 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 0 • n=5 Participants
|
33 years
STANDARD_DEVIATION 14 • n=7 Participants
|
45 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine HCL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine
n=1 participants at risk
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
|
Ropivacaine HCL
n=2 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Mild edema
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Musculoskeletal and connective tissue disorders
mild muscle spasms
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Psychiatric disorders
hallucination
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Nervous system disorders
diaphoresis
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Immune system disorders
fever
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Blood and lymphatic system disorders
elevated systolic blood pressure
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Cardiac disorders
tachycardia
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Nervous system disorders
moderate orthostatic hypotension
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place