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Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06300606
Acronym
NOL and LRA
Enrollment
25
Registered
2024-03-08
Start date
2024-03-05
Completion date
2024-04-15
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Monitoring, Pain, Regional Anesthesia

Keywords

nociception, regional anesthesia, intraoperative monitoring, NOL monitor

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.

Interventions

DEVICENOL monitoring

Prospective observational study to assess pain during regional anesthesia for upper limb orthopedic surgery using NOL monitoring and the Algoplus pain scale

Sponsors

Nataliya KARASHCHUK
CollaboratorUNKNOWN
Briana LUI
CollaboratorUNKNOWN
Thierry GUENOUN
CollaboratorUNKNOWN
Stephane ROMANO
CollaboratorUNKNOWN
American Hospital of Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pain scoreintraoperativeNociception index level monitoring NOL

Secondary

MeasureTime frameDescription
sedative requirementintraoperativepropofol
anxiolytic requirementintraoperativemidazolam
failure of regional anesthesiaintraoperativegeneral conversion or sufentanil requirement

Countries

France

Contacts

Primary ContactGilles BOCCARA, MD, PhD
gilles.boccara@ahparis.org+33 6 62 38 28 33
Backup Contactthierry GUENOUN, MD
thierry.guenoun@ahparis.org+ 33 1 46 41 26 91

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026