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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to assess pain during labor using a device called the Nociception Level Index (NOL Index). The goal is to see how well this device can monitor pain levels in women receiving epidural anesthesia, which is a common method for managing labor pain. The NOL Index measures the body's response to pain in a non-invasive way, which could help healthcare providers better understand and manage pain during childbirth.

To participate in the study, women must be over 18 years old, in labor, and requesting epidural pain relief. They should also have a certain level of pain, as measured by a simple pain scale. However, there are some exclusions, such as having certain medical conditions or a high body weight. Participants will have their pain levels assessed through the NOL Index and will be asked about their pain experience, while also being monitored for any side effects. This research aims to improve pain relief methods for women during labor, ensuring both safety and comfort.

Gender

FEMALE

Eligibility 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)