Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422585
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-26
Brief Title:
Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
Sponsor:
Azienda Ospedaliero Universitaria Pisana
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery The main question it aims to answer is
Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in
Researchers will compare the Femoral Nerve GroupIPACK block the Saphenous Nerve blockIPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery
Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in
Researchers will compare the Femoral Nerve GroupIPACK block the Saphenous Nerve blockIPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery
Detailed Description:
After adequate venous access is obtained a light sedation with Midazolam 1-2 mg is administered The patient will be monitored and a selective spinal anesthesia will be performed After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic
Magnesium Solfate 1g and Dexametasone 4mg are administered after the block If the patient wishes a propofol continuos infusion may be administered for sedation during the surgery Before the patient leaves the OR Ketorolac 30mg will be administered
Pain control after surgery will be achieved with acetaminophen 1g tid Ketorolac 30mg on demand and Morphine solfate if NRS 5 after Ketorolac
Every 6 hours the patient will be monitored by the anesthesia team After 24 hours the antalgic effect of the nerve block is reasonably thought to be over so the follow up is interrupted
Magnesium Solfate 1g and Dexametasone 4mg are administered after the block If the patient wishes a propofol continuos infusion may be administered for sedation during the surgery Before the patient leaves the OR Ketorolac 30mg will be administered
Pain control after surgery will be achieved with acetaminophen 1g tid Ketorolac 30mg on demand and Morphine solfate if NRS 5 after Ketorolac
Every 6 hours the patient will be monitored by the anesthesia team After 24 hours the antalgic effect of the nerve block is reasonably thought to be over so the follow up is interrupted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None