Labor PainNCT05898737
Nociception Level Index (NOL Index) for Obstetrical Pain Assessment Under Epidural Analgesia.
An observational study of Labor Pain and Nociceptive Pain, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Pain has been defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Nociceptive Pain, Epidural Analgesia
- What is being tested?
- NOL-Index
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2023to 31 Dec 2023
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women in labour requesting an epidural analgesia
Who may be able to join
- Patients > 18 years old, able to self-report
- American Society of Anesthesiologists (ASA) score I to II
- Gestational age > 36 weeks of amenorrhea
- Primiparous or multiparous
- In labour
- Request and indication for epidural analgesia
- Height 160-175cm
- Intensity of pain objectified by Visual Analogue Scale (VAS) > 3/10
Who cannot join
- Patient refusal
- Contraindications to epidural analgesia (allergy to local anesthetics, coagulopathy, local infections)
- BMI > 40 kg/m2
- Weight > 110kg
- History of caesarean section
- Pre-eclampsia or pregnancy-induced hypertension
Show all 13Show fewer
- Cardiac arrhythmias (including atrial fibrillation)
- Treatment with β-blockers
- Chronic opioid use
- History of substance abuse/dependency
- Psychiatric pathology (including depression, psychosis, etc.)
- Total language barrier
- Epidurals at uncomfortable times (night)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint-Pierre
Brussels, Bruxelles-Capitale, Région de, 1000
Lucia Moron Liberio, MD, 025353098, lucia.moron@stpierre-bru.be
About this study
Official title: The Interest of the Nociception Index (Nociception Level Index, NOL Index) for the Evaluation of Obstetric Pain Under Epidural Analgesia: a Prospective Pilot Study
Pain has been defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Labour pain is the pain experienced during labour and childbirth and it's characterised by nociceptive pain accompanied by sympathetic activation.
Since more than fifty years, the development of hospital obstetric assistance for labour, allowed the implementation of the pain relief culture in the demanding parturients population.
Read more
The ideal labour analgesic technique should provide consistent pain relief at any stage of labour, have a long duration of action, while being safe both for the mother and the foetus. It should also anticipate undesirable side effects, such as motor block.
The current gold standard for obstetric analgesia is the lumbar epidural technique using the administration of local anesthetics combined with opioids. However, the best administration mode is currently under debate, the main interest being the local anesthetic sparing responsible for various maternal side effects and the quality of maternal analgesia.
Despite the intense research in the field, the evaluation of the labour pain remains difficult as performed by the midwife and the anesthesiologist based on the patient's behaviour and her subjective self-assessment.
The PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel) is a non-invasive multiparametric nociception monitoring that has proved its interest in the intraoperative evaluation of patient's physiological response to pain under general anesthesia, using the NOL index variation. Nonetheless, it has been barely investigated in patients receiving locoregional anesthesia and never in the context of obstetrical pain.
The investigators support the idea that the NOL index monitoring could allow us to assess the degree of nociceptive stimulation related to obstetric labour and its variation under epidural analgesia, as well as to compare the efficacy of sensitive block using different epidural administration modes.
The aim of this pilot study is to evaluate the NOL Index variation during labour pain management with epidural analgesia.
The investigators will focus on the evaluation of analgesia in relation with the self-reported pain intensity, and secondly, the characteristics of the sensory block, the hemodynamic variables and side effects.
Read the detailed description
- Design: The investigators will conduct a prospective, repeated measures, monocentric, observational pilot study. The study will be carried out in the anesthesia department of the Saint Pierre University Hospital in collaboration with the obstetrics department. Parturient women in labour admitted into the delivery room, during the beginning of the first stage of labour demanding for an epidural will be recruited after signed written informed consent. The number of patients to be included has been calculated to be 55.
- Anesthetic management: An epidural will be placed, initiated and maintained by the investigators according to the department's usual practice (including monitoring, technique and pump protocol). The epidural will be considered successful when the sensitive block has reached a T10 level within maximum 30 minutes. If the patient is not relieved within 30 minutes a new bolus readministration will be administered by the Patient-Controlled Epidural Analgesia (PCEA) pump. In case of:
- Dura mater breach : exclusion of the patient from the protocol
- Venous puncture : epidural replacement at another level
- Hypotension (defined as a 20% drop in baseline blood pressure) needing vasopressors
- Hypotension and fetal heart rate abnormalities
- Nociception monitoring NOL Index is based on several variables nonlinear combination of heart rate, heart rate variability, photoplethysmograph wave amplitude, skin conductance, skin conductance fluctuations, and their time derivatives and variation upon activation of the sympathetic nervous system in response to a stimuli. The normal range of the NOL index has been set between 10 and 25, a value above 25 indicates that the patient is experiencing a nociceptive stimulation.
The monitoring will be placed on the contralateral side to the non invasive blood pressure (NIBP) upon recruitment and it will be calibrated during 30 seconds to 2 minutes period of time without uterine contraction, objectified by the toco monitoring and confirmed by the parturient before epidural placement.
Consented patients will be taught how to use the 0-10 numeric rating scales (NRS) to report pain intensity (where zero indicates no pain and 10 indicates the worst possible pain).
The NOL monitor will be hidden throughout the procedure, to reduce any bias during self-reporting.
The patient will be asked to report the self-evaluated pain at each contraction using the NRS scale during the initial 15 minutes following the initial bolus.
The characteristics of the block achieved (sensory and motor), analgesic and hemodynamic variables will be collected throughout the study period (1 hour after the implementation of the epidural) at several time points as follows :
T0 - Epidural request T1 - End of loading dose (bolus) T2 - Loading dose + 15 mins T3 - Loading dose + 30 mins T4 - Loading dose + 45 mins T5 - Loading dose + 60 mins
If a supplementary bolus is needed (PCEA) all the aforementioned variables will be collected.
- Conditions
- Labor Pain, Nociceptive Pain, Epidural Analgesia, NOL Index
- Being tested
- NOL-Index
- Keywords
- Labor pain, Epidural analgesia, NOL Index
- Medical subject headings
- Labor Pain, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOL-IndexDevice
Also called PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel)
NOL Index monitoring with the PMD100™ (Medasense Biometrics Ltd.)
| Study group | Role | What they receive |
|---|---|---|
| Parturients | Parturients on labour requiring an epidural Receives: Device: NOL-Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOL Index variation (Delta-NOL)
NOL Index variation between nociceptive (contraction) and non-nociceptive (rest) periods following the implementation of the epidural
Measured: 1 hour after the epidural implementation
Secondary outcomes (14)
Nociception level
Mesured by the NOL Index value (0-100). Higher scores meaning higher nociceptive stimuli.
Measured: 1 hour after the epidural implementation
Parturient's self-reported pain intensity
Numerical Rating Scale (NRS) by the patient (0-10). Higher scores meaning more painful stimuli.
Measured: 1 hour after the epidural implementation
Maternal satisfaction
Yes/no answer
Measured: 1 hour after the epidural implementation
Sensory block
Sensory block using the cold ether test (maximal anatomical dermatome with a sensory block).
Measured: 1 hour after the epidural implementation
Motor block
Motor block using the modified Bromage scale (0-4). Higher scores meaning more motor block.
Measured: 1 hour after the epidural implementation
Local anesthetic total dose
Total dose of local anesthetics received by the epidural (mg)
Measured: 1 hour after the epidural implementation
Opioids total dose
Total dose of opioids received by the epidural (mcg)
Measured: 1 hour after the epidural implementation
Need for PCEA rescue bolus
Number of supplementary boluses if patient is unconfortable after 20 minutes.
Measured: 1 hour after the epidural implementation
Need of change in pump parameters
Number of changes in pump parameters if patient is unconfortable after 20 minutes.
Measured: 1 hour after the epidural implementation
Blood pressure
Systolic and diastolic blood pressure, measured by the non invasive blood pressure cuff (mmHg)
Measured: 1 hour after the epidural implementation
Heart rate
Mesured by pulse oximetry (bpm)
Measured: 1 hour after the epidural implementation
Oxygen saturation
Mesured by pulse oximetry (%)
Measured: 1 hour after the epidural implementation
Symptomatic hypotension
Side effects such as symptomatic hypotension (yes/no answer).
Measured: 1 hour after the epidural implementation
Nausea/vomiting
Side effects such as nausea/vomiting (yes/no answer).
Measured: 1 hour after the epidural implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start20 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, MD, PhD, Study director, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898737
- Sponsor's protocol ID
- B0762023230305
- Status last verified
- Sep 2023
- First submitted
- 17 Apr 2023
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interest of the Nociception Index (Nociception Level Index, NOL Index) for the Evaluation of Obstetric Pain Under Epidural Analgesia: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT05898737
- Acronym / sponsor ID
- B0762023230305
- Conditions
- Labor Pain, Nociceptive Pain, Epidural Analgesia, NOL Index
- Keywords
- Labor pain, Epidural analgesia, NOL Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Jun 2023 (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.
Pain has been defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Labour pain is the pain experienced during labour and childbirth and it's characterised by nociceptive pain accompanied by sympathetic activation.
Since more than fifty years, the development of hospital obstetric assistance for labour, allowed the implementation of the pain relief culture in the demanding parturients population.
The ideal labour analgesic technique should provide consistent pain relief at any stage of labour, have a long duration of action, while being safe both for the mother and the foetus. It should also anticipate undesirable side effects, such as motor block.
The current gold standard for obstetric analgesia is the lumbar epidural technique using the administration of local anesthetics combined with opioids. However, the best administration mode is currently under debate, the main interest being the local anesthetic sparing responsible for various maternal side effects and the quality of maternal analgesia.
Despite the intense research in the field, the evaluation of the labour pain remains difficult as performed by the midwife and the anesthesiologist based on the patient's behaviour and her subjective self-assessment.
The PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel) is a non-invasive multiparametric nociception monitoring that has proved its interest in the intraoperative evaluation of patient's physiological response to pain under general anesthesia, using the NOL index variation. Nonetheless, it has been barely investigated in patients receiving locoregional anesthesia and never in the context of obstetrical pain.
The investigators support the idea that the NOL index monitoring could allow us to assess the degree of nociceptive stimulation related to obstetric labour and its variation under epidural analgesia, as well as to compare the efficacy of sensitive block using different epidural administration modes.
The aim of this pilot study is to evaluate the NOL Index variation during labour pain management with epidural analgesia.
The investigators will focus on the evaluation of analgesia in relation with the self-reported pain intensity, and secondly, the characteristics of the sensory block, the hemodynamic variables and side effects.
Detailed description
- Design: The investigators will conduct a prospective, repeated measures, monocentric, observational pilot study. The study will be carried out in the anesthesia department of the Saint Pierre University Hospital in collaboration with the obstetrics department. Parturient women in labour admitted into the delivery room, during the beginning of the first stage of labour demanding for an epidural will be recruited after signed written informed consent. The number of patients to be included has been calculated to be 55.
- Anesthetic management: An epidural will be placed, initiated and maintained by the investigators according to the department's usual practice (including monitoring, technique and pump protocol). The epidural will be considered successful when the sensitive block has reached a T10 level within maximum 30 minutes. If the patient is not relieved within 30 minutes a new bolus readministration will be administered by the Patient-Controlled Epidural Analgesia (PCEA) pump. In case of:
- Dura mater breach : exclusion of the patient from the protocol
- Venous puncture : epidural replacement at another level
- Hypotension (defined as a 20% drop in baseline blood pressure) needing vasopressors
- Hypotension and fetal heart rate abnormalities
- Nociception monitoring NOL Index is based on several variables nonlinear combination of heart rate, heart rate variability, photoplethysmograph wave amplitude, skin conductance, skin conductance fluctuations, and their time derivatives and variation upon activation of the sympathetic nervous system in response to a stimuli. The normal range of the NOL index has been set between 10 and 25, a value above 25 indicates that the patient is experiencing a nociceptive stimulation.
The monitoring will be placed on the contralateral side to the non invasive blood pressure (NIBP) upon recruitment and it will be calibrated during 30 seconds to 2 minutes period of time without uterine contraction, objectified by the toco monitoring and confirmed by the parturient before epidural placement.
Consented patients will be taught how to use the 0-10 numeric rating scales (NRS) to report pain intensity (where zero indicates no pain and 10 indicates the worst possible pain).
The NOL monitor will be hidden throughout the procedure, to reduce any bias during self-reporting.
The patient will be asked to report the self-evaluated pain at each contraction using the NRS scale during the initial 15 minutes following the initial bolus.
The characteristics of the block achieved (sensory and motor), analgesic and hemodynamic variables will be collected throughout the study period (1 hour after the implementation of the epidural) at several time points as follows :
T0 - Epidural request T1 - End of loading dose (bolus) T2 - Loading dose + 15 mins T3 - Loading dose + 30 mins T4 - Loading dose + 45 mins T5 - Loading dose + 60 mins
If a supplementary bolus is needed (PCEA) all the aforementioned variables will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients | – | Device: NOL-IndexParturients on labour requiring an epidural |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women in labour requesting an epidural analgesia
Key inclusion criteria (8 listed)
- Patients > 18 years old, able to self-report
- American Society of Anesthesiologists (ASA) score I to II
- Gestational age > 36 weeks of amenorrhea
- Primiparous or multiparous
- In labour
Key exclusion criteria (13 listed)
- Patient refusal
- Contraindications to epidural analgesia (allergy to local anesthetics, coagulopathy, local infections)
- BMI > 40 kg/m2
- Weight > 110kg
- History of caesarean section
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-IndexAlso: PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel)NOL Index monitoring with the PMD100™ (Medasense Biometrics Ltd.) | Device | Parturients |
Primary outcome
NOL Index variation (Delta-NOL)
Time frame: 1 hour after the epidural implementation
NOL Index variation between nociceptive (contraction) and non-nociceptive (rest) periods following the implementation of the epidural
14 secondary outcomes
Nociception level
Time frame: 1 hour after the epidural implementation
Parturient's self-reported pain intensity
Time frame: 1 hour after the epidural implementation
Maternal satisfaction
Time frame: 1 hour after the epidural implementation
Sensory block
Time frame: 1 hour after the epidural implementation
Motor block
Time frame: 1 hour after the epidural implementation
Local anesthetic total dose
Time frame: 1 hour after the epidural implementation
Opioids total dose
Time frame: 1 hour after the epidural implementation
Need for PCEA rescue bolus
Time frame: 1 hour after the epidural implementation
Need of change in pump parameters
Time frame: 1 hour after the epidural implementation
Blood pressure
Time frame: 1 hour after the epidural implementation
Heart rate
Time frame: 1 hour after the epidural implementation
Oxygen saturation
Time frame: 1 hour after the epidural implementation
Symptomatic hypotension
Time frame: 1 hour after the epidural implementation
Nausea/vomiting
Time frame: 1 hour after the epidural implementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
Panayota Kapessidou, MD, PhD study director
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain and Nociceptive Pain, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Moron Liberio, MD (025353098, lucia.moron@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOL Index variation (Delta-NOL) (time frame: 1 hour after the epidural implementation). 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 13 Sep 2023.