Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT06300606
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'intraoperative', 'description': 'Nociception index level monitoring NOL'}, {'measure': 'pain score', 'timeFrame': 'intraoperative', 'description': 'ALGOPLUS pain scale'}], 'secondaryOutcomes': [{'measure': 'sedative requirement', 'timeFrame': 'intraoperative', 'description': 'propofol'}, {'measure': 'anxiolytic requirement', 'timeFrame': 'intraoperative', 'description': 'midazolam'}, {'measure': 'failure of regional anesthesia', 'timeFrame': 'intraoperative', 'description': 'general conversion or sufentanil requirement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nociception', 'regional anesthesia', 'intraoperative monitoring', 'NOL monitor'], 'conditions': ['Regional Anesthesia', 'Pain', 'Intraoperative Monitoring']}, 'referencesModule': {'references': [{'pmid': '31327102', 'type': 'BACKGROUND', '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.'}, {'pmid': '35925430', 'type': 'BACKGROUND', '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.'}, {'pmid': '37374370', 'type': 'BACKGROUND', '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.'}, {'pmid': '34908872', 'type': 'RESULT', '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 Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.'}, {'pmid': '34783941', 'type': 'RESULT', '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 Clin Monit Comput. 2022 Jun;36(3):623-635. doi: 10.1007/s10877-021-00772-3. Epub 2021 Nov 16.'}, {'pmid': '35643392', 'type': 'RESULT', '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) 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': '27171828', 'type': 'RESULT', 'citation': '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': '30997633', 'type': 'RESULT', '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 noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.'}, {'pmid': '26154185', 'type': 'RESULT', '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;123(3):524-34. doi: 10.1097/ALN.0000000000000757.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMethod: 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.\n\nPain 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all the patients scheduled to undergo an upper limb orthopedic surgery under regional anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nscheduled upper limb orthopedic surgery under regional anesthesia\n\nExclusion Criteria:\n\nPatient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease'}, 'identificationModule': {'nctId': 'NCT06300606', 'acronym': 'NOL and LRA', 'briefTitle': 'Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'American Hospital of Paris'}, 'officialTitle': 'Is the Regional Anesthesia Technique Painful? an Evaluation Using the Nociception Index Level (NOL), a New Pain Monitoring, and Algiscore, a Multidimensional Pain Score', 'orgStudyIdInfo': {'id': 'NOL1 and RA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NOL monitoring', 'type': 'DEVICE', 'otherNames': ['regional anesthesia'], 'description': 'Prospective observational study to assess pain during regional anesthesia for upper limb orthopedic surgery using NOL monitoring and the Algoplus pain scale'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles BOCCARA', 'role': 'CONTACT', 'email': 'gilles.boccara@ahparis.org', 'phone': '+33662382833'}, {'name': 'thierry GUENOUN', 'role': 'CONTACT', 'email': 'thierry.guenoun@ahparis.org', 'phone': '+33146412691'}], 'facility': 'Gilles BOCCARA', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}], 'centralContacts': [{'name': 'Gilles BOCCARA, MD, PhD', 'role': 'CONTACT', 'email': 'gilles.boccara@ahparis.org', 'phone': '+33 6 62 38 28 33'}, {'name': 'thierry GUENOUN, MD', 'role': 'CONTACT', 'email': 'thierry.guenoun@ahparis.org', 'phone': '+ 33 1 46 41 26 91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Hospital of Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nataliya KARASHCHUK', 'class': 'UNKNOWN'}, {'name': 'Briana LUI', 'class': 'UNKNOWN'}, {'name': 'Thierry GUENOUN', 'class': 'UNKNOWN'}, {'name': 'Stephane ROMANO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiologist, MD, PhD', 'investigatorFullName': 'Gilles BOCCARA', 'investigatorAffiliation': 'American Hospital of Paris'}}}}