NCT06300606

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 3, 2024

Last Update Submit

March 7, 2024

Conditions

Regional AnesthesiaPainIntraoperative Monitoring

Keywords

nociceptionregional anesthesiaintraoperative monitoringNOL monitor

Outcome Measures

Primary Outcomes (2)

  • pain score

    Nociception index level monitoring NOL

    intraoperative

  • pain score

    ALGOPLUS pain scale

    intraoperative

Secondary Outcomes (3)

  • sedative requirement

    intraoperative

  • anxiolytic requirement

    intraoperative

  • failure of regional anesthesia

    intraoperative

Interventions

NOL monitoringDEVICE

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

Also known as: regional anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • scheduled upper limb orthopedic surgery under regional anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilles BOCCARA

Neuilly-sur-Seine, 92200, France

RECRUITING

Related Publications (9)

  • 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.

    PMID: 31327102BACKGROUND

  • 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.

    PMID: 35925430BACKGROUND

  • 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.

    PMID: 37374370BACKGROUND

  • 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.

    PMID: 34908872RESULT

  • 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.

    PMID: 34783941RESULT

  • 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.

    PMID: 35643392RESULT

  • 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.

    PMID: 27171828RESULT

  • 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.

    PMID: 30997633RESULT

  • 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.

    PMID: 26154185RESULT

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Gilles BOCCARA, MD, PhD

CONTACT

+33 6 62 38 28 33gilles.boccara@ahparis.org

thierry GUENOUN, MD

CONTACT

+ 33 1 46 41 26 91thierry.guenoun@ahparis.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist, MD, PhD

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 8, 2024

Study Start

March 5, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)