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This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.
This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.
Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle. | |
| Liposomal Bupivacaine with Bupivacaine | Experimental | Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine with Bupivacaine | Drug | Pain medications injected locally during surgery around affected ankle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels on a Visual Analog Scale ( VAS) | A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels. | Immediate post-operative period until 72 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Davidovitch, MD | Jamaica Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23977664 | Background | Owen RT. Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992. | |
| 25830260 | Background | Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN. Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia |
| FG001 | Liposomal Bupivacaine With Bupivacaine | Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
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| Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia |
| BG001 | Liposomal Bupivacaine With Bupivacaine |
| 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 | Pain Levels on a Visual Analog Scale ( VAS) | A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels. | Posted | Mean | Standard Deviation | units on a scale | Immediate post-operative period until 72 hours post-operatively |
|
Patients were assessed for the development of any adverse events from the time of initial consent and enrollment through the their 6 month functional outcomes follow up.
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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 | Control | Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Driesman | Department of Orthopaedic Surgery, NYU Langone Orthopaedic Hospital | 2033315938 | Adam.Driesman@nyumc.org |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 25750943 | Background | Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7. |
| 25614060 | Background | Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22. |
| NOT COMPLETED |
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Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Full Range | kilogram per meter squared |
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| Charlson Comorbidity Index (CCI) | The CCI is a validated index used to quantitatively measure the number and severity of a patient's co-morbid illnesses. A specific grading chart for the various types and severity of illnesses is used that ranges from 0 points (i.e., no active disease process) to 6 points (i.e., most severe active disease process). Each illness is assigned a point value according to the scale, and the presence and severity of each illness are summed for an individual patient. A score of 0 indicates no active co-morbid illnesses within a patient, whereas a score >0 suggests 1 or more active disease processes. | Mean | Full Range | units on a scale |
|
| OTA Fracture Classification | The number of participants within each ankle fracture classification using the groupings provided by the Orthopaedic Trauma Association (OTA) (i.e., 44A, 44B, 44C) was determined. The numbering indicates the anatomic location of the fractures (i.e., 44 designates fractures of the tibia and/or fibula malleoli [ankle]). The lettering indicates the relative location of the fracture in regards to the location of the syndesmotic joint connecting the tibia and fibula such that A indicates fractures below this joint, B indicates fractures involving the joint, and C indicate fractures above the joint. | Count of Participants | Participants |
|
| OG000 |
| Control |
Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia |
| OG001 | Liposomal Bupivacaine With Bupivacaine | Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle. |
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| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Liposomal Bupivacaine With Bupivacaine | Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle. | 0 | 37 | 0 | 37 |
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| D000588 |
| Amines |