Nociceptive PainNCT04305015
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
A study testing NOL Guided Analgesia and Routine opioid management in people with Nociceptive Pain, run by Medasense Biometrics Ltd at 1 site in United States.
Trial summary
Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Nociceptive Pain
- What is being tested?
- NOL Guided Analgesia and Routine opioid management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 30 Dec 2020
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults having major non-cardiac surgery expected to last ≥2 hours;
- American Society of Anesthesiologists physical status 1-3;
- Age 21-85 years old;
- Planned endotracheal intubation
Who cannot join
- Planned neuraxial or regional block;
- Local anesthetic infiltration at surgical field;
- Clinician preference for an opioid other than, or in addition to, fentanyl;
- Non-sinus heart rhythm;
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
- Lack of English language fluency;
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- Routine user of psychoactive drugs other than opioids;
- Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
- Intracranial surgery
- BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Benefits of Intraoperative NOL Titration - Pilot
Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.
- Conditions
- Nociceptive Pain
- Being tested
- NOL Guided Analgesia, Routine opioid management
- Keywords
- NOL, Nociception
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOL Guided AnalgesiaDevice
Also called Physiological Monitoring Device: PMD-200 system
NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends
Routine opioid managementOther
Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement
| Study group | Role | What they receive |
|---|---|---|
| Routine opioid management | Active comparator | Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when Receives: Other: Routine opioid management |
| NOL-guided opioid administration | Experimental | Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients Receives: Device: NOL Guided Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU pain score
Average pain scores (0-10 verbal response scale) at 10-minute intervals during the initial 60 minutes of recovery are more often between 1 and 3 or significantly lower with NOL-guided fentanyl than with routine care
Measured: 60 minutes during recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start9 Nov 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- NOL-Guided analgesia vs. Routine Management
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305015
- Sponsor's protocol ID
- CLI-20-01
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Benefits of Intraoperative NOL Titration - Pilot
- ClinicalTrials.gov ID
- NCT04305015
- Acronym / sponsor ID
- CLI-20-01
- Conditions
- Nociceptive Pain
- Keywords
- NOL, Nociception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Mar 2020 (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.
Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- NOL-Guided analgesia vs. Routine Management
| Arm | Type | Receives |
|---|---|---|
| Routine opioid management | Active comparator | Other: Routine opioid managementClinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when |
| NOL-guided opioid administration | Experimental | Device: NOL Guided AnalgesiaClinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults having major non-cardiac surgery expected to last ≥2 hours;
- American Society of Anesthesiologists physical status 1-3;
- Age 21-85 years old;
- Planned endotracheal intubation
Key exclusion criteria (10 listed)
- Planned neuraxial or regional block;
- Local anesthetic infiltration at surgical field;
- Clinician preference for an opioid other than, or in addition to, fentanyl;
- Non-sinus heart rhythm;
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
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 |
|---|---|---|
| NOL Guided AnalgesiaAlso: Physiological Monitoring Device: PMD-200 systemNOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends | Device | NOL-guided opioid administration |
| Routine opioid managementClinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement | Other | Routine opioid management |
Primary outcome
PACU pain score
Time frame: 60 minutes during recovery
Average pain scores (0-10 verbal response scale) at 10-minute intervals during the initial 60 minutes of recovery are more often between 1 and 3 or significantly lower with NOL-guided fentanyl than with routine care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOL Guided Analgesia and Routine opioid management in people with Nociceptive Pain, run by Medasense Biometrics Ltd at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 6 May 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PACU pain score (time frame: 60 minutes during recovery). 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 6 May 2021.