Periarticular Injection Versus Popliteal Block
- Registration Number
- NCT04575688
- Lead Sponsor
- Campbell Clinic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Periarticular Injection Exparel 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. Popliteal Block Bupivicaine 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.
- Primary Outcome Measures
Name Time Method Evidence of motor block Postoperative hour 3 Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"
Visual Analog Score Postoperative week 12 Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
- Secondary Outcome Measures
Name Time Method Document pain medication prescribed immediately after surgery 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.
Neuralgia symptoms: survey question Postoperative week 12 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.
Pill count Postoperative week 12 Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."
Document pain medication prescribed at postoperative week 2 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.
Document pain medication prescribed at postoperative week 6 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.
Satisfaction with pain control: survey question Postoperative week 12 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.
Document pain medication prescribed at postoperative week 12 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.
Trial Locations
- Locations (1)
A
🇺🇸Germantown, Tennessee, United States