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This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periarticular Injection | Active Comparator | Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure. |
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| Popliteal Block | Active Comparator | Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 3 |
| Evidence of motor block | Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?" | Postoperative hour 3 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 6 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 12 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 24 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 36 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative hour 48 |
| Visual Analog Score |
| Measure | Description | Time Frame |
|---|---|---|
| Document pain medication prescribed immediately after surgery | Pain medication prescribed immediately after the surgery will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed immediately after surgery, to include opiate name, dose, and number of pills prescribed. | Immediately after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garnett A Murphy, MD | Campbell Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A | Germantown | Tennessee | 38138 | United States |
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| Bupivicaine | Drug | Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair. |
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Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
| Postoperative hour 72 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative week 2 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative week 4-6 |
| Visual Analog Score | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain | Postoperative week 12 |
| Satisfaction with pain control: survey question | Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied. | Postoperative week 2 |
| Neuralgia symptoms: survey question | Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia. | Postoperative week two |
| Pill count | Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time." | Postoperative week 2 |
| Document pain medication prescribed at postoperative week 2 | Pain medication prescribed at postoperative week 2 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 2, to include opiate name, dose, and number of pills prescribed. | Postoperative week 2 |
| Satisfaction with pain control: survey question | Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied. | Postoperative week 6 |
| Neuralgia symptoms: survey question | Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia. | Postoperative week 6 |
| Pill count | Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time." | Postoperative week 6 |
| Document pain medication prescribed at postoperative week 6 | Pain medication prescribed at postoperative week 6 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 6, to include opiate name, dose, and number of pills prescribed. | Postoperative week 6 |
| Satisfaction with pain control: survey question | Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied. | Postoperative week 12 |
| Neuralgia symptoms: survey question | Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia. | Postoperative week 12 |
| Pill count | Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time." | Postoperative week 12 |
| Document pain medication prescribed at postoperative week 12 | Pain medication prescribed at postoperative week 12 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 12, to include opiate name, dose, and number of pills prescribed. | Postoperative week 12 |