Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600815
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty a Prospective Double-blind Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty TKA Eligible patients will be included in this study after signing the informed consent form Before TKA the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia PSIA group or a postoperative local infiltration analgesia PLIA group and administered different pain management protocols during surgery Clinical evaluation will be conducted at baseline before surgery and at 6 12 24 48 and 72 hours postoperatively as well as during follow-up visits at 3 weeks 6 weeks and 6 months postoperatively All patients voluntarily participated in the study and signed informed consent During the treatment period all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6 12 24 48 72 and 96 weeks later aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA to explore the optimal perioperative analgesic modality for TKA
Detailed Description:
This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty TKA This study aims to recruit 110 patients across a single centre over 1 year Eligible patients will be included in this study after signing the informed consent form Before TKA the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia PSIA group or a postoperative local infiltration analgesia PLIA group and administered different pain management protocols during surgery Clinical evaluation will be conducted at baseline before surgery and at 6 12 24 48 and 72 hours postoperatively as well as during follow-up visits at 3 weeks 6 weeks and 6 months postoperatively The primary outcomes are the amount of morphine consumed within 0-24 hours postsurgery and the visual analogue scale VAS score postsurgery Secondary outcomes include the time to first rescue analgesia total morphine consumption during hospitalization postoperative joint function measured by the Hospital for Special Surgery HSS score and knee joint range of motion ROM intraoperative bleeding and serological indicators All patients voluntarily participated in the study and signed informed consent During the treatment period all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6h 12h 24h 48h 72h 3 weeks 6 weeks and 6 months later aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA to explore the optimal perioperative analgesic modality for TKA Statistical analyses utilizing regression models and survival analysis will be conducted to assess the relationships between the pain management method and postoperative pain and efficacy
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