Foot Surgery, Ankle Surgery
Conditions
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.
Interventions
DRUGExparel
Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
DRUGBupivicaine
Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
Sponsors
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score | Postoperative hour 3 | Patient reported pain score from zero to ten where zero is no pain and ten is the most pain |
| Evidence of motor block | Postoperative hour 3 | Patient reported yes/no answer to survey question: Are you able to wiggle your toes? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuralgia symptoms: survey question | Postoperative week two | 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 2 | Patient reported fill-in-the-blank answer to survey question: Total number of pain pills taken during this time. |
| 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. |
| 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. |
| 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. |
| 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. |
| Satisfaction with pain control: survey question | Postoperative week 2 | 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. |
Countries
United States
Outcome results
None listed