Ankle Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Pain medications injected locally during surgery around affected ankle.
Sponsors
Jamaica Hospital Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients at least 18 years old. 2. Male or Female 3. All racial and ethnic groups 4. Fractures and fracture/dislocations of the ankle 5. Patients who opt for surgical treatment of their fractures. 6. Patients who consent to be randomized. 7. Patients who are willing to follow-up for a minimum of 52 weeks.
Exclusion criteria
1. Patients younger than 18 years old 2. Patients who are on chronic opioids 3. Patients who abuse opioids 4. Patients who are unwilling to follow-up for a minimum of 52 weeks 5. Neurologic condition that could interfere with pain sensation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels on a Visual Analog Scale ( VAS) | Immediate post-operative period until 72 hours post-operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| 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. | 37 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow Up | Lost to Follow-up | 4 | 2 |
| Randomization | Surgeon did not give intervention | 0 | 1 |
| Randomization | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Liposomal Bupivacaine With Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 32 Participants | 70 Participants |
| Age, Continuous | 42.6 years | 41.9 years | 42 years |
| Body Mass Index (BMI) | 29.7 kilogram per meter squared | 29.4 kilogram per meter squared | 29.5 kilogram per meter squared |
| Charlson Comorbidity Index (CCI) | 0.9 units on a scale | 0.8 units on a scale | 0.88 units on a scale |
| OTA Fracture Classification 44A | 12 Participants | 8 Participants | 20 Participants |
| OTA Fracture Classification 44B | 16 Participants | 19 Participants | 35 Participants |
| OTA Fracture Classification 44C | 11 Participants | 10 Participants | 21 Participants |
| Region of Enrollment United States | 39 Participants | 37 Participants | 76 Participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 20 Participants | 18 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 37 |
| serious Total, serious adverse events | 0 / 39 | 0 / 37 |
Outcome results
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.
Time frame: Immediate post-operative period until 72 hours post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Pain Levels on a Visual Analog Scale ( VAS) | 4 Hours Post-operative | 7.05 units on a scale | Standard Deviation 2.87 |
| Control | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 1 | 7.49 units on a scale | Standard Deviation 1.92 |
| Control | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 2 | 6.64 units on a scale | Standard Deviation 2.01 |
| Control | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 3 | 5.72 units on a scale | Standard Deviation 1.91 |
| Liposomal Bupivacaine With Bupivacaine | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 3 | 4.08 units on a scale | Standard Deviation 1.85 |
| Liposomal Bupivacaine With Bupivacaine | Pain Levels on a Visual Analog Scale ( VAS) | 4 Hours Post-operative | 4.03 units on a scale | Standard Deviation 3.5 |
| Liposomal Bupivacaine With Bupivacaine | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 2 | 5.22 units on a scale | Standard Deviation 1.81 |
| Liposomal Bupivacaine With Bupivacaine | Pain Levels on a Visual Analog Scale ( VAS) | Post-operative Day 1 | 6.60 units on a scale | Standard Deviation 1.85 |
p-value: <0.1t-test, 2 sided