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Regional AnesthesiaNOL and LRANCT06300606

Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

An observational study of Regional Anesthesia and Pain, run by American Hospital of Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
NOL monitoring
Type of treatment
Medical device
How many people
25 participants
Where
1 siteFrance
Study dates
5 Mar 2024to 15 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: all the patients scheduled to undergo an upper limb orthopedic surgery under regional anesthesia

Who may be able to join

  • scheduled upper limb orthopedic surgery under regional anesthesia

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Gilles BOCCARA, MD, PhD contact

+33 6 62 38 28 33

gilles.boccara@ahparis.org

thierry GUENOUN, MD contact

+ 33 1 46 41 26 91

thierry.guenoun@ahparis.org

France1 site, 1 recruiting

  • Gilles BOCCARA

    Neuilly-sur-Seine, 92200

    Gilles BOCCARA, +33662382833, gilles.boccara@ahparis.org

    thierry GUENOUN, +33146412691, thierry.guenoun@ahparis.org

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
NOL monitoring
Keywords
nociception, regional anesthesia, intraoperative monitoring, NOL monitor
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOL monitoringDevice

    Also called regional anesthesia

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain score

    Nociception index level monitoring NOL

    Measured: intraoperative

  2. pain score

    ALGOPLUS pain scale

    Measured: intraoperative

Secondary outcomes (3)

  1. sedative requirement

    propofol

    Measured: intraoperative

  2. anxiolytic requirement

    midazolam

    Measured: intraoperative

  3. failure of regional anesthesia

    general conversion or sufentanil requirement

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start5 Mar 2024 (estimated)
  3. Primary completion15 Apr 2024 (estimated)
  4. Study completion15 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06300606
Sponsor's protocol ID
NOL1 and RA
Acronym
NOL and LRA
Status last verified
Mar 2024
First submitted
3 Mar 2024
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meijer FS, Niesters M, van Velzen M, Martini CH, Olofsen E, Edry R, Sessler DI, van Dorp ELA, Dahan A, Boon M. Does nociception monitor-guided anesthesia affect opioid consumption? A systematic review of randomized controlled trials. J Clin Monit Comput. 2020 Aug;34(4):629-641. doi: 10.1007/s10877-019-00362-4. Epub 2019 Jul 20.

    PubMed 31327102

  • Morisson L, Nadeau-Vallee M, Espitalier F, Laferriere-Langlois P, Idrissi M, Lahrichi N, Gelinas C, Verdonck O, Richebe P. Prediction of acute postoperative pain based on intraoperative nociception level (NOL) index values: the impact of machine learning-based analysis. J Clin Monit Comput. 2023 Feb;37(1):337-344. doi: 10.1007/s10877-022-00897-z. Epub 2022 Aug 4.

    PubMed 35925430

  • Neumann C, Gehlen L, Weinhold L, Strassberger-Nerschbach N, Soehle M, Kornilov E, Thudium M. Influence of Intraoperative Nociception during Hip or Knee Arthroplasty with Supplementary Regional Anaesthesia on Postoperative Pain and Opioid Consumption. Medicina (Kaunas). 2023 Jun 17;59(6):1166. doi: 10.3390/medicina59061166.

    PubMed 37374370

  • Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.

    PubMed 34908872

  • Shahiri TS, Richebe P, Richard-Lalonde M, Gelinas C. Description of the validity of the Analgesia Nociception Index (ANI) and Nociception Level Index (NOL) for nociception assessment in anesthetized patients undergoing surgery: a systematized review. J Clin Monit Comput. 2022 Jun;36(3):623-635. doi: 10.1007/s10877-021-00772-3. Epub 2021 Nov 16.

    PubMed 34783941

  • Ghiyasinasab M, Morisson L, Laferriere-Langlois P, Geraldo-Demers MA, Gelinas C, Nadeau-Vallee M, Verdonck O, Lahrichi N, Richebe P. Identification of the intraoperative antinociceptive effect of intravenous fentanyl using the Nociception Level (NOL) index versus clinical parameters in patients undergoing gynecological laparoscopic surgery: A secondary analysis of the NOLGYN study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101102. doi: 10.1016/j.accpm.2022.101102. Epub 2022 May 25.

    PubMed 35643392

  • Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.

    PubMed 27171828

  • Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

    PubMed 30997633

  • Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.

    PubMed 26154185

Questions about this trial

What is this clinical trial studying?

An observational study of Regional Anesthesia and Pain, run by American Hospital of Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gilles BOCCARA, MD, PhD (+33 6 62 38 28 33, gilles.boccara@ahparis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06300606, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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