Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519955
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Can PLIA Reduce Early Post-operative Pain After PAO Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PILA PAO
Brief Summary:
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
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
Detailed Description:
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 111 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None