Nociception Monitoring During Epidural Analgesia

NCT06456177 | Completed

• 1 other identifier: 0056-21-CMC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Relief

Keywords

Epidural Analgesia; Visual Analogue Scale; Nociception Level Index

Outcome Measures

Primary Outcomes (2)

• Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Visual Analog Scale (VAS)

  The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by reporting the Visual Analog Scale (VAS) displayed as a scale from 1-10, with 0 representing no nociception and 10 representing extreme nociception, when higher scores mean a worse outcome

  60 minutes

• Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Nociception Level (NOL) index

  The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by monitoring the Nociception Level (NOL) index displayed as a scale from 0-100 with 0 representing no nociception and 100 representing extreme nociception, when higher scores mean a worse outcome.

  60 minutes

Interventions

Assessment of nociception in obstetric patients during epidural analgesia DEVICE

Comparing nociception in obstetric patients during epidural analgesia, subjectively, by Visual analog scale and objectively by monitoring Nociception level Index

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women parturient , age between 20-45 years Present pregnancy is their second, Singleton births, third trimester of pregnancy, delivery conducted under Epiduarl analgesia

You may qualify if:

• Parturient
• Age between 20-45 years
• Present pregnancy istheir second
• Singleton births
• Under Epiduarl analgesia

You may not qualify if:

• Age younger than 20 years or older than 45 years
• First pregnancy
• Multiple birth

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 3436212, Israel

Location

Study Officials

• Dana Koos, Dr. MD

  danako@clalit.org.il

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of outpatient pain medicine clinic

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: June 30, 2021
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

IL (1)