PainNCT06804434
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
A study testing Lidocaine Intravenous Infusion and NOL in people with Pain and Anesthesia, run by Osoian Cristiana at 1 site in Romania.
Trial summary
This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anesthesia, Perioperative Care
- What is being tested?
- Lidocaine Intravenous Infusion and NOL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRomania
- Study dates
- 18 May 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- ASA score I-III
- surgery for gastric or hepatobiliary or pancreatic neoplasia
Who cannot join
- pregnancy
- lactation
- neuraxial or regional anesthesia
- chronic treatment with drugs that can influence autonomic nervous system
- diuretics or nitroglycerin administration on the day of surgery
- severe neurological disability
Show all 14Show fewer
- severe hemodynamic instability
- chronic pain
- chronic opioid treatment
- allergy to any of the study drugs
- severe untreated disease or organ failure
- pacemaker
- emergency surgery
- patient refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Regional Gastroenterology and Hepatology Institute Octavian Fodor
Cluj-Napoca, Cluj
Cristiana Osoian, +40743352189, osoiancris@yahoo.com
Cristiana Osoian
About this study
This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.
- Conditions
- Pain, Anesthesia, Perioperative Care
- Being tested
- Lidocaine Intravenous Infusion, NOL
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Intravenous InfusionDrug
intravenous lidocaine 10 mg/ml continuous infusion
NOLDevice
Intraoperative Nociception Level index monitoring and guided analgesia
| Study group | Role | What they receive |
|---|---|---|
| + NOL + lidocaine group | Experimental | NOL guided analgesia and intravenous lidocaine infusion Receives: Drug: Lidocaine Intravenous Infusion; Device: NOL |
| - NOL - lidocaine group | No intervention | group without NOL monitoring or lidocaine administration |
| + NOL - lidocaine group | Experimental | NOL guided analgesia without intravenous lidocaine infusion Receives: Device: NOL |
| - NOL + lidocaine group | Experimental | group without NOL monitoring but with lidocaine intravenous infusion Receives: Drug: Lidocaine Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid use
We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg
Measured: intraoperative
Secondary outcomes (6)
Intraoperative pulse
Mean pulse rate and peak pulse rate
Measured: intraoperative
Intraoperative blood pressure
Mean blood pressure and peak blood pressure
Measured: intraoperative
Postoperative pain scores
VAS score at 15 minutes, 30 minute, 2 hours 4 hours, 12 hours and 24 hours
Measured: 24 hours
Postoperative opioid use
Measured: 24 hours
Lidocaine related adverse events
Measured: 24 hours
Opioid related adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start18 May 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osoian Cristiana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osoian Cristiana, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804434
- Sponsor's protocol ID
- NOL-1047
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
- ClinicalTrials.gov ID
- NCT06804434
- Acronym / sponsor ID
- NOL-1047
- Conditions
- Pain, Anesthesia, Perioperative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Osoian CristianaUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| + NOL + lidocaine group | Experimental | Drug: Lidocaine Intravenous Infusion, Device: NOLNOL guided analgesia and intravenous lidocaine infusion |
| - NOL - lidocaine group | No intervention | –group without NOL monitoring or lidocaine administration |
| + NOL - lidocaine group | Experimental | Device: NOLNOL guided analgesia without intravenous lidocaine infusion |
| - NOL + lidocaine group | Experimental | Drug: Lidocaine Intravenous Infusiongroup without NOL monitoring but with lidocaine intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- ASA score I-III
- surgery for gastric or hepatobiliary or pancreatic neoplasia
Key exclusion criteria (14 listed)
- pregnancy
- lactation
- neuraxial or regional anesthesia
- chronic treatment with drugs that can influence autonomic nervous system
- diuretics or nitroglycerin administration on the day of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Intravenous Infusionintravenous lidocaine 10 mg/ml continuous infusion | Drug | + NOL + lidocaine group, - NOL + lidocaine group |
| NOLIntraoperative Nociception Level index monitoring and guided analgesia | Device | + NOL + lidocaine group, + NOL - lidocaine group |
Primary outcome
Intraoperative opioid use
Time frame: intraoperative
We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg
6 secondary outcomes
Intraoperative pulse
Time frame: intraoperative
Intraoperative blood pressure
Time frame: intraoperative
Postoperative pain scores
Time frame: 24 hours
Postoperative opioid use
Time frame: 24 hours
Lidocaine related adverse events
Time frame: 24 hours
Opioid related adverse events
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Intravenous Infusion and NOL in people with Pain and Anesthesia, run by Osoian Cristiana at 1 site in Romania.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristiana Osoian (+40743352189, osoiancris@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative opioid use (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.