The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are: 1. Does PLIA impact post-operative pain after PAO? 2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO? 3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart. Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.
Patients will be approached at their preoperative appointment. This is the only time researchers will conduct study related activities with patients. All other information will be gathered by chart review. Following consent, patients will be asked to complete surveys through REDCap® using a tablet or computer. These include a self-efficacy survey and a grit survey. Patients will then be randomized in a 1:1:1 ratio. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO. Patients will be blinded to which group they are in, meaning they will not know whether they received the injection or not. Patients may ask to be told what study group they were in at their standard-of-care, 3 month follow-up visit. Following surgery, patients in all treatment arms will be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled as needed per standard of care. The research team will review patient medical records to record narcotic use and visual analog scale (VAS) pain scores post-operatively until discharge from the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
Weight 50-74.9 kg: * ropivacaine 100mg/epinephrine 50 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 75-99.9 kg: * Ropivacaine 150mg/epinephrine 100 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 100+ kg: * Ropivacaine 200mg/epinephrine 150 mcg/ketorolac 15 mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total
University of Iowa Health Care
Iowa City, Iowa, United States
RECRUITINGPost-operative pain after periacetabular osteotomy.
Severity of pain will be measured by collection of the visual analog scale (VAS) for pain. Scale of 1-10.
Time frame: Post Anesthesia Care Unit (PACU), 24 hours post op
Pain medication usage after periacetabular osteotomy.
The amount of pain medications taken will be measured using morphine equivalent dosing (MED).
Time frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
The impact of timing of PLIA administration on post-operative pain.
The mean VAS pain will be compared between the different study groups. Scale of 1-10.
Time frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
The impact of timing of PLIA administration on MED.
The mean MED will be compared between the different study groups.
Time frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
Assessment on depression (PHQ-9)
A scale to measure depression will be collected to determine the impact on early post-operative pain. Scale of 0-27.
Time frame: Preoperative
General Self-Efficacy Scale (GSE)
Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40
Time frame: Preoperative
Pain Resilience Scale.
Scale on pain resilience (grit) will be collected to determine the impact on early post-operative pain. The scale provides two scores, Behavioral Perseverance on a scale of 0-20 and Cognitive/Affective Positivity on a scale of 0-36.
Time frame: Preoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.