An observational study in Pain, Opioid Use and Intraoperative Complications, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Vermont · Observational
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Among 2,881 studies in Pain with a site in United States — 315 open to participants now, 393 under way, 24 of them phase 3. Pain · United States.
Among the 2,881 studies in Pain with a site in United States, this one is the 182nd largest by enrollment of the 299 observational ones that give a count, is one of 128 that started in 2018, is one of 300 observational ones, and was the 1,832nd registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →315 of the 2,881 studies in Pain with a site in United States are open now. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 30–75
Vanderbilt University Medical Center · Sites in United States
Ages 18+
Columbia University · Sites in United States
Ages 6–17
Hospital for Special Surgery, New York · Sites in United States
Ages 18–80 · Healthy volunteers
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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2,881 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 249 · Phase 2 416 · Phase 3 374 · Phase 4 372
First in 1957; this study’s year is marked. 128 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 61 is below the median of 100 across 1,253 observational studies indexed under Pain.
Median enrollment 66 across the 2,559 interventional studies, 99 across the 299 observational. Of the 2,224 that completed or were terminated, 1,051 (47%) have results posted.
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670 of 2,881 have an industry lead sponsor. The 10 most frequent:
University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
University of Vermont has 2 studies filed under Pain — fewer than ten, so there is no comparison to draw.
171 of the studies in Pain with a site in United States that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07226258Phase 3Saol Therapeutics IncPhase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain | 2026-11-30 |
| NCT05964868Phase 3Jessyka LighthallEfficacy of Liposomal Bupivacaine Post Septorhinoplasty | 2026-12 |
| NCT07832552Phase 3Harrow IncA Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery | 2026-12 |
| NCT03823534Phase 3St. Louis UniversityPost-Op Pain Control for Prophylactic Intramedullary Nailing. | 2026-12-31 |
| NCT07276542Phase 3The Ketamine Research FoundationClinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved. | 2026-12-31 |
Add all 171 to your calendar (.ics) → With an account.
Among the 2,881 studies in Pain with a site in United States, from their registry updates:
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A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state.
The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient.
All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.
The primary efficacy objective of this study is to demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration), and the secondary efficacy objective of the study is to determine whether the NOL values can be correlated to other nociception predictors (e.g., increase in heart rate or blood pressure) following a noxious stimuli. The primary safety objective of this study is to assess the rate of any adverse reaction related to the study device. This device will not be used to make any clinical decision.
General anesthesia is the combination of various components including lack of movement, hypnosis, amnesia, control of autonomic responses, and attenuation of the response to noxious stimulation. Some anesthetic components, such as muscle relaxation and absence of movement are easy to assess with a twitch monitor. Similarly, hypnotic state can be estimated using processed electroencephalographic signals, but the anesthetic component that remains the most challenging to assess is the nociceptive/antinociceptive state. Typically, intraoperative nociception is estimated from autonomic responses (such as change in blood pressure and heart rate) and clinical signs such as tearing and sweating, but these variables can be very unreliable in predicting pain such as in patients who take beta blockers for treatment of high blood pressure whose heart rate may not increase in response to pain, patients with significant bleeding during surgery whose blood pressure may not increase in response to pain, etc. Effective antinociception is an important component of balanced anesthesia and appears to enhance postoperative outcomes. The most obvious potential consequence of insufficient intraoperative antinociceptive treatment is excessive postoperative pain, but inadequate treatment may also promote inflammatory, hormonal, and immunologic imbalances.
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these components measures using random forest regression. Previous experimental work on a small number of patients showed that the NoL index is superior to each individual component and to a linear combination of the components. However, it remains unknown whether the NoL index accurately quantifies patients' intraoperative responses to noxious stimuli of varying intensities. The investigators therefore wish to evaluate the ability of the NoL index to discriminate noxious from nonnoxious stimuli, respond to analgesic administration, and progressively increase in response to increasing intensity of noxious stimulation.
In this observational study, The investigators attempt to learn the proper use of the PMD-200 and assess safety and efficacy of this device as mentioned above; however, no clinical decision will be based on the NoL index obtained.
Adult patients ASA I-III scheduled for general anesthesia for laparoscopic GI or GU procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will be monitored by PMD-200 device
Device: NoL Index
Use of the PMD-200 in an observational study
The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use
To demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration). Specifically, the investigators will assess the % change from baseline-steady state NoL Index value with the NoL Index value during surgical stimulation (increased noxious stimulation) as well as the NoL Index value after administration of analgesics (decreased noxious stimulation).
Time frame: Intraoperatively
the secondary efficacy objective: Correlation of NoL Index with changes in heart rate
To determine whether the NOL values can be correlated to other nociception predictors (increase in heart rate) following a noxious stimuli.
Time frame: Intraoperatively
the secondary efficacy objective: Correlation of NoL Index with blood pressure
To determine whether the NOL values can be correlated to other nociception predictors (increase in blood pressure) following a noxious stimuli.
Time frame: Intraoperatively
Safety objective: Any adverse reaction related to device
To assess the rate of any adverse reaction related to the study device, any skin irritation or other unforeseen adverse reactions will be recorded.
Time frame: Intraoperatively
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Dec 2018, 8 months.
Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 8 months is below that.
Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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