A Phase 3 interventional study of Liposomal Bupivacaine with Bupivacaine in Ankle Fracture, sponsored by Jamaica Hospital Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Jamaica Hospital Medical Center · Phase 3, Interventional, and Treatment
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.
194 studies on the registry are indexed under Ankle Fractures; 46 are open to participants now.
This study's enrollment of 84 is close to the median of 93 across 147 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Jamaica Hospital Medical Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle.
Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.
Drug: Liposomal Bupivacaine with Bupivacaine
Pain medications injected locally during surgery around affected ankle.
Also known as: Exparel
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.
Time frame: Immediate post-operative period until 72 hours post-operatively
| Milestone | Control | Liposomal Bupivacaine With Bupivacaine |
|---|---|---|
| Started | 44 | 40 |
| Completed | 43 | 39 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Surgeon did not give intervention | 0 | 1 |
| Milestone | Control | Liposomal Bupivacaine With Bupivacaine |
|---|---|---|
| Started | 43 | 39 |
| Completed | 39 | 37 |
| Not completed | 4 | 2 |
| Withdrew: Lost to follow-up | 4 | 2 |
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.
| units on a scale | Control | Liposomal Bupivacaine With Bupivacaine |
|---|---|---|
| 4 Hours Post-operative | 7.05 ± 2.87 | 4.03 ± 3.50 |
| Post-operative Day 1 | 7.49 ± 1.92 | 6.60 ± 1.85 |
| Post-operative Day 2 | 6.64 ± 2.01 | 5.22 ± 1.81 |
| Post-operative Day 3 | 5.72 ± 1.91 | 4.08 ± 1.85 |
Collected over 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.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/39 (0%) | 0/39 (0%) |
| Liposomal Bupivacaine With Bupivacaine | — | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 32 | 70 |
| >=65 years | 1 | 5 | 6 |
| Age, Continuous(years) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| Mean | 42.6 (19 to 69) | 41.9 (19 to 81) | 42 (19 to 81) |
| Sex: Female, Male(Participants) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| Female | 19 | 19 | 38 |
| Male | 20 | 18 | 38 |
| Region of Enrollment(Participants) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| United States | 39 | 37 | 76 |
| Body Mass Index (BMI)(kilogram per meter squared) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| Mean | 29.7 (19.1 to 42) | 29.4 (17.9 to 48.1) | 29.5 (17.9 to 48.1) |
| Charlson Comorbidity Index (CCI)(units on a scale) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| Mean | 0.9 (0 to 3) | 0.8 (0 to 5) | 0.88 (0 to 5) |
| OTA Fracture Classification(Participants) | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| 44A | 12 | 8 | 20 |
| 44B | 16 | 19 | 35 |
| 44C | 11 | 10 | 21 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Jamaica Hospital Medical Center