Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300606
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Brief Title:
Nociception Index Level NOL Perioperative Monitoring During Regional Anesthesia
Sponsor:
American Hospital of Paris
Organization:
American Hospital of Paris
Study Overview
Official Title:
Is the Regional Anesthesia Technique Painful an Evaluation Using the Nociception Index Level NOL a New Pain Monitoring and Algiscore a Multidimensional Pain Score
Status:
RECRUITING
Status Verified Date:
2024-03
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:
NOL and LRA
Brief Summary:
This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia The locoregional anesthesia was performed under ultrasound with or without neurostimulation Intraoperative pain is assessed using NOL index monitoring ALGISCORE and Numerical Scale and second point study is the midazolam and propofol requirement
Detailed Description:
Introduction Intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation Recently the Nociception Level index NOL providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia While this monitoring has also been used postoperatively in awake patients data are scarce to assess pain under locoregional anesthesia This study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb
Method 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included Exclusion criteria were emergencies request for general anesthesia and patients under 18 years of age All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice After premedication with oral hydroxyzine locoregional anesthesia was performed under ultrasound with or without neurostimulation Monitoring began as soon as the venous infusion was started and parameters were recorded at the time of locoregional anesthesia tourniquet inflation surgical incision skin closure and dressing
Pain is also assessed using the ALGISCORE by the nurse and the numerical scale 0 to 5 and satisfaction score at the end of the procedure The need to administer midazolam or propofol at the anesthetists discretion is noted as is the effectiveness of locoregional anesthesia conversion to general anesthesia Data were analyzed using Friedman and Mann-Whitney tests
Method 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included Exclusion criteria were emergencies request for general anesthesia and patients under 18 years of age All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice After premedication with oral hydroxyzine locoregional anesthesia was performed under ultrasound with or without neurostimulation Monitoring began as soon as the venous infusion was started and parameters were recorded at the time of locoregional anesthesia tourniquet inflation surgical incision skin closure and dressing
Pain is also assessed using the ALGISCORE by the nurse and the numerical scale 0 to 5 and satisfaction score at the end of the procedure The need to administer midazolam or propofol at the anesthetists discretion is noted as is the effectiveness of locoregional anesthesia conversion to general anesthesia Data were analyzed using Friedman and Mann-Whitney tests
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