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| ID | Type | Description | Link |
|---|---|---|---|
| D6.715L15J91110 | Other Grant/Funding Number | Defense Health Program |
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Poor recruitment
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Active Comparator | In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered |
|
| Ropivacaine HCL | Placebo Comparator | In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Brown, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Med Center- Trauma and Acute Care Surgery | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Requirements | Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents | There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study. | Posted | 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. |
|
Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild edema | Blood and lymphatic system disorders | Non-systematic Assessment | Mild edema at the site of IV placement. |
There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian Brown | UC Davis | (916)734-1279 | iebrown@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2019 | Dec 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2019 | Dec 9, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Ropivacaine HCL | 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. |
|
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
| 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 | There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study. | Posted | 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. |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
|
| mild muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hallucination | Psychiatric disorders | Non-systematic Assessment | one episode of nighttime hallucination |
|
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | pruritus of lower extremity opposite injury |
|
| diaphoresis | Nervous system disorders | Non-systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| fever | Immune system disorders | Non-systematic Assessment |
|
| elevated systolic blood pressure | Blood and lymphatic system disorders | Non-systematic Assessment | present prior to study enrollment |
|
| tachypnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment | intermittent nausea post-op |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| moderate orthostatic hypotension | Nervous system disorders | Non-systematic Assessment | Moderate orthostatic hypotension (treated with normal saline bolus) |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D000588 |
| Amines |