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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No medication administration. Standard of care medications will be offered. | |
| Post Closure | Active Comparator | Once the fascia has been closed, the PLIA will be administered using a pediatric catheter. |
|
| Throughout Procedure | Active Comparator | The injection will be performed throughout the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) | Combination Product | Weight 50-74.9 kg:
Weight 75-99.9 kg:
Weight 100+ kg:
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-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. | 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). | 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. | 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. | Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative |
| General Self-Efficacy Scale (GSE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley S Kochuyt | Contact | 319-384-5101 | ashley-kochuyt@uiowa.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40
| 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. | Preoperative |
| D025981 |
| Hip Injuries |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |