Clinical trial NCT06300606: Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Regional Anesthesia
Pain
Intraoperative Monitoring
Keywords: nociception
regional anesthesia
intraoperative monitoring
NOL monitor
Lead sponsor: American Hospital of Paris
Sponsor class: OTHER
Collaborators: name: Nataliya KARASHCHUK
name: Briana LUI
name: Thierry GUENOUN
name: Stephane ROMANO
First posted: 2024-03-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all the patients scheduled to undergo an upper limb orthopedic surgery under regional anesthesia

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 anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). Data were analyzed using Friedman and Mann-Whitney tests.

Eligibility criteria: Inclusion Criteria:

scheduled upper limb orthopedic surgery under regional anesthesia

Exclusion Criteria:

Patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease

Primary outcomes:
measure: pain score
timeFrame: intraoperative
measure: pain score
timeFrame: intraoperative
Secondary outcomes:
measure: sedative requirement
timeFrame: intraoperative
measure: anxiolytic requirement
timeFrame: intraoperative
measure: failure of regional anesthesia
timeFrame: intraoperative
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Gilles BOCCARA
Study officials:
References:
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