Nociception Level Index (NOL Index) for Obstetrical Pain Assessment Under Epidural Analgesia.

NCT05898737 | Unknown

• 1 other identifier: B0762023230305
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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". 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.

Conditions

Labor Pain; Nociceptive Pain; Epidural Analgesia; NOL Index

Keywords

Labor pain; Epidural analgesia; NOL Index

Outcome Measures

Primary Outcomes (1)

• NOL Index variation (Delta-NOL)

  NOL Index variation between nociceptive (contraction) and non-nociceptive (rest) periods following the implementation of the epidural

  1 hour after the epidural implementation

Secondary Outcomes (14)

• Nociception level

  1 hour after the epidural implementation

• Parturient's self-reported pain intensity

  1 hour after the epidural implementation

• Maternal satisfaction

  1 hour after the epidural implementation

• Sensory block

  1 hour after the epidural implementation

• Motor block

  1 hour after the epidural implementation

Study Arms (1)

Parturients

Parturients on labour requiring an epidural

Device: NOL-Index

Interventions

NOL-Index DEVICE

NOL Index monitoring with the PMD100™ (Medasense Biometrics Ltd.)

Also known as: PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel)

Parturients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Parturient population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in labour requesting an epidural analgesia

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, Bruxelles-Capitale, Région de, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Labor Pain; Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Panayota Kapessidou, MD, PhD

  Centre Hospitalier Universitaire Saint Pierre

  STUDY DIRECTOR

Central Study Contacts

Lucia Moron Liberio, MD

CONTACT

025353098; lucia.moron@stpierre-bru.be

Philippe Goffard, MD

CONTACT

025353799; philippe.goffard@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 12, 2023
• Study Start: June 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)