Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06456177 |
| Other study ID # |
0056-21-CMC |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2021 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Carmel Medical Center |
| Contact |
Michael Grach, Dr. MD |
| Phone |
97248250625 |
| Email |
Michaelgr4[@]clalit.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Introduction and aim: Nociception monitors have been used to assess pain management in
anesthetized patients. The investigators set out to evaluate whether Nociception Level (NOL)
monitor (PMD-200 monitor with NOL technology , (Medasense Biometrics Ltd. Ramat Gan, Israel)
yields reliable readings during labor, and whether the derived NOL index will be associated
with Visual analogue scale (VAS) subjective level of pain before and after the onset of
epidural analgesia.
Methods:
Following approval by the intuitional review board No 0056-21-CMC, thirty parturients
scheduled for epidural analgesia due to labor pains will be included in this prospective
study, after informed consent for participation in the study will be obtained. NOL monitoring
device will be connected to the subject finger. Epidural analgesia will be performed as per
institutional standards. Data of VAS and NOL index will be collected once a minute. The
association between VAS and NOL before and after the onset of adequate analgesia will be
evaluated.
Description:
Introduction:
Epidural analgesia is the most effective method of labor pain relief to this day. The lumbar
epidural analgesia aims to induce a sensory block from T10 to L1, while at the same time
facilitating the motor action of the lower limbs (L2-L5), thereby enabling the continued
cooperation of the mother in the birth process.
Pain assessment is crucial for pain management and to date relies almost solely on subjective
monitoring using self-assessment scales of the subject, which can be affected by personality,
behavior, and psychological characteristics. Objective tools to measure pain have been
developed. They rely on the changes in the balance between sympathetic and parasympathetic
activity and include the heart rate variability, blood pressure, skin electrical conductivity
and the vasomotor reflex and the electroencephalogram pupil. Nociception represents the
integrated response to painful stimuli including the neural, hormonal and behavioral
activity. Combination of multiple nociception-related parameters yielded stronger
associations with the noxious stimuli compared with each parameter alone.
The PMD-200 monitor with NOL technology (Medasense Biometrics Ltd. Ramat Gan, Israel) is a
novel, propriety, monitoring device based on a combination of nociception related
physiological variables including heart rate, heart rate variability, photo-plethysmographic
waveforms, skin conductance, and their time derivative. Based on a random forest model, the
device generates the Nociception level (NOL) index, displayed as a scale from 0-100 with 0
representing no nociception and 100 representing extreme nociception. A NOL level of less
than 25 arbitrary units is associated with adequate analgesia in patients under general
anesthesia.
So far, the objective assessment of pain has been restricted mainly to patients who were
under general anesthesia. Data in conscious patients is scant . The study design is to
evaluate how nociception changes in the awake patients, and especially, how its changes
following blockade of the painful stimuli. Study population parturients who will be scheduled
to receive epidural analgesia for labor. This allow us to study the nociceptive level index
during uterine contractions before and after the onset of epidural analgesia.
Methods:
Following approval by the intuitional review board No 0056-21-CMC, 30 parturients will be
recruited and signed informed consent will be obtained.
Study protocol:
Visual analogue scale (VAS) will evaluated every 3-5 minutes and maximal NOL value within a
30 second interval will be recorded as the corresponding NOL value. Study duration will be up
to 40 minutes following adequate pain relief. Total duration up to 60 minutes per parturient.
Epidural analgesia will be performed according to the protocol procedure in our institution
(either sitting or lateral position with loss of resistance with either air or saline).
Following insertion of an epidural catheter, a test dose of 40 mg of lidocaine will be
injected to exclude spinal placement. 3 minutes later a bolus of 10 ml of 0.125% bupivacaine
and 50 mcg fentanyl will be administered. VAS and NOL evaluation will proceed for up to 30
minutes after epidural analgesia commenced.
Definitions:
Baseline values (No pain relief values) are those collected before analgesia was achieved.
Post epidural analgesia (Pain relief values) are those collected after the commencement of
analgesia. That is after VAS dropped to 50% of highest baseline values Inadequate Epidural:
Parturients who still had a VAS > 50% of BL VAS 20 minutes after epidural injection. They
were treated conventionally to control pain either by additional injection of local
anesthetic, a repeated epidural or other modes of pain relief. Once diagnosed as failed
epidural further data was not collected.
Outcomes:
The effect of pain relief using neuroaxial epidural analgesia in awake patients with
intermittent painful stimuli (uterine contractions) the association between VAS and NOL will
be evaluated.
Data analysis The measurements will be divided according to the pain status: adequate pain
relief and no pain relief. The NOL and VAS distribution while with and without pain relief
will be presented with Box-plots and the mean, standard deviation, median, interquartile
range (IQR) and range. For each woman, the difference between the mean VAS measured while
having no pain relief and the mean VAS measured while having adequate pain relief will be
calculated. The difference between the VAS score with and without pain relief was compared
using Wilcoxon signed rank test. P<0.05 was considered statistically significant. The same
analysis will be performed for NOL values (separately).
As each pain evaluation included both NOL and VAS values, a LOESS - Local Regression, which
is a nonparametric technique that uses local weighted regression to fit a smooth curve
through points in a scatter plot, will be performed. The LOESS purpose is to demonstrate the
association between the VAS and the NOL.
In order to present the pain measurements along the time since the follow-up onset, a LOESS
curves will be also performed. The statistical analysis and data management will be conducted
using SAS 9.4 software (SAS Institute Inc., Cary, NC, USA.).
