Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

Pain Clinical Trial

— NOL and LRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300606
• Other study ID #: NOL1 and RA
• Status: Recruiting
• Start date: March 5, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: American Hospital of Paris
• Contact: Gilles BOCCARA, MD, PhD
• Phone: +33 6 62 38 28 33
• Email: gilles.boccara[@]ahparis.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Monitoring
• Pain
• Regional Anesthesia

Intervention

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

Locations

Country	Name	City	State
France	Gilles BOCCARA	Neuilly-sur-Seine

Sponsors (5)

Lead Sponsor	Collaborator
American Hospital of Paris	Briana LUI, Nataliya KARASHCHUK, Stephane ROMANO, Thierry GUENOUN

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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 N — View Citation

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) inde — View Citation

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;12 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 noxi — View Citation

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 Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	Nociception index level monitoring NOL	intraoperative
Primary	pain score	ALGOPLUS pain scale	intraoperative
Secondary	sedative requirement	propofol	intraoperative
Secondary	anxiolytic requirement	midazolam	intraoperative
Secondary	failure of regional anesthesia	general conversion or sufentanil requirement	intraoperative