Periarticular Injection Versus Popliteal Block

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures

Conditions
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Foot Surgery, Ankle Surgery

Intervention / Treatment
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* Drug: Exparel
* Drug: Bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankle or hindfoot osteotomy or ankle fracture repair Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138) 18-80 years of age ASA I-III with medical clearances as needed Fluent ub verbal and written English Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study Willing and able to provide written consent Exclusion Criteria: Diagnosed with chronic pain syndrome History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents Injury associated with workers' compensation Surgery to be performed at a hospital Diagnosed with peripheral neuropathy Hbg A1C is > 7 mg/dl in diabetic patients only Long term (chronic) preoperative narcotic usage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Periarticular Injection<br>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. | Drug: Exparel<br>* Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.<br>|
| Active Comparator: Popliteal Block<br>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. | Drug: Bupivicaine<br>* Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |