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Additional published information on the topic since starting the study
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Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients.
Liposomal bupivacaine has gained interest in recent literature for its potential to be an effective adjunct to other pain control modalities in a multi-modal approach to post-operative pain control. Liposomal bupivacaine is an analgesic that is suspended in lipids to allow for gradual release of the analgesic over a 72-hour period (NAMDARI). From prior literature, the utilization of local analgesics infiltrated into surgical sites have been shown to reduce pain in the immediate post-operative period in foot and ankle surgery (GADEK). However, the evaluation of liposomal bupivacaine in foot and ankle surgery is limited. One prospective study found that the addition to liposomal bupivacaine to a multi-modal pain management protocol for forefoot surgery resulted in decreased pain scores during the first four post-operative days as well as fewer refills of opioid pain medication prescriptions, although both findings were not statically significant (ROBBINS). As the general medical community and public policy makers continue to focus on decreasing the amount of opioid pain medications prescribed and available in the community due to the opioid epidemic, liposomal bupivacaine has the potential to be a useful adjunct in the management of post-operative pain without reliance on opioid prescriptions. The goal of this investigation is to compare the efficacy of local administration of liposomal bupivacaine versus the efficacy of a peripheral nerve block in terms of post-operative pain scores after elective ankle and hindfoot surgery. The investigators hypothesize that there will not be a significant difference in the pain scores of these two groups in opioid naïve patients. Furthermore, this study aims to determine if there are differences in the amount of opioid medications utilized for post-operative pain control, patient satisfaction scores, functional outcomes, complications, and unscheduled healthcare contact between the two groups. In order to accomplish these aims, a randomized, controlled investigation will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Group | Experimental | No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. |
|
| Peripheral Nerve Block Group | Active Comparator | Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Score | Best 0-10 worst - Continuous scale to measure current pain level | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents | morphine equivalents consumed for post-operative pain control | 0-6 weeks |
| Investigator-developed, Pain Satisfaction Score | asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cush, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Woodbine | Danville | Pennsylvania | 17821 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine Group | No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area |
| FG001 | Peripheral Nerve Block Group | Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only 1 baseline participant included as only 1 total participant was enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine Group | No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area |
| BG001 | Peripheral Nerve Block Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Analog Scale Pain Score | Best 0-10 worst - Continuous scale to measure current pain level | One participant analyzed at baseline as only one total participant was enrolled. No data was displayed at 6 weeks time frame because data was not collected by investigator(s)." | Posted | Number | score on a scale | Baseline and 6 weeks |
|
From date of surgery to 6-weeks post surgery.
An adverse event (AE) is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study.
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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 Group | No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerard Cush | Geisinger Medical Center | 5702716700 | MSKIresearch@geisinger.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2019 | Dec 6, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Peripheral Nerve Block | Drug | Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). |
|
| 0-6 weeks |
| Range of Motion | range of motion measured using goniometer | 0-6 weeks |
| Number of Participants With Complications | complications after surgery including infection and delayed healing | 6 weeks |
| Number of Participants With Unscheduled Healthcare Contact | unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits | 6 weeks |
Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration
Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
|
|
| Secondary | Morphine Equivalents | morphine equivalents consumed for post-operative pain control | Data was not collected by investigator(s). | Posted | 0-6 weeks |
|
|
| Secondary | Investigator-developed, Pain Satisfaction Score | asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied | Data was not collected by investigator(s). | Posted | 0-6 weeks |
|
|
| Secondary | Range of Motion | range of motion measured using goniometer | Data was not collected by investigator(s). | Posted | 0-6 weeks |
|
|
| Secondary | Number of Participants With Complications | complications after surgery including infection and delayed healing | One participant analyzed as only one total participant was enrolled. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of Participants With Unscheduled Healthcare Contact | unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits | One participant analyzed as only one total participant was enrolled. | Posted | Count of Participants | Participants | 6 weeks |
|
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|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Peripheral Nerve Block Group | Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). | 0 | 0 | 0 | 0 | 0 | 0 |
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