Assessing Pain Levels in Labor with Epidural Analgesia
The Interest of the Nociception Index (Nociception Level Index, NOL Index) for the Evaluation of Obstetric Pain Under Epidural Analgesia: a Prospective Pilot Study
This study is testing a new way to measure pain in women during labor who are using epidurals to see if it can help improve their pain management and overall childbirth experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre Academic / other |
| Locations | 1 site (Bruxelles, Bruxelles-Capitale, Région De) |
| Trial ID | NCT05898737 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to evaluate the effectiveness of the Nociception Level Index (NOL Index) in assessing labor pain in women receiving epidural analgesia. Conducted at the Saint Pierre University Hospital, the study will recruit parturient women in labor who request an epidural, monitoring their pain levels and the effectiveness of the analgesia. The study will include 55 participants and will utilize a combination of heart rate, skin conductance, and other physiological measures to assess nociception. The goal is to improve pain management during labor and enhance the overall childbirth experience.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old, in labor, requesting epidural analgesia, and with a pain intensity of greater than 3/10 on the Visual Analogue Scale.
Not a fit: Patients with contraindications to epidural analgesia, such as severe obesity or certain medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women in labor, enhancing their childbirth experience.
How similar studies have performed: While the NOL Index is a novel approach in this context, similar studies have shown promise in pain assessment and management during labor.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Bruxelles, Bruxelles-Capitale, Région De
- CHU Saint-Pierre — Bruxelles, Bruxelles-Capitale, Région De, Belgium (Recruiting)
Study contacts
- Study coordinator: Lucia Moron Liberio, MD
- Email: lucia.moron@stpierre-bru.be
- Phone: 025353098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.