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The Application of Analgesia Nociception Index as an Objective Labor Pain Assessment During Epidural Analgesia

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ClinicalTrials.gov Identifier: NCT03975816
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Changhua Christian Hospital

Brief Summary:
Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.

Condition or disease Intervention/treatment
Labor Pain Device: Analgesia nociception index

Detailed Description:

Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. Without a convincing objective tool for obstetric pain evaluation during epidural analgesia, the clinicians are hard to adjust adequate epidural drug dosage. Establishing an objective pain index would help the clinicians to have a better pain management during labor.

In 2012, M. Le Guen et al. demonstrated a linear relationship between visual analogical pain scores(VAS) and Analgesia Nociception Index (ANI) values during labor. Their efforts started the application of ANI in obstetric pain monitoring. However, the reliability of ANI in obstetric pain monitoring under epidural analgesia have not yet been verified. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changhua Christian Hospital, Department of Anesthesiology
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Analgesia nociception index
    Monitor the maternity with Analgesia nociception index


Primary Outcome Measures :
  1. The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score [ Time Frame: 90 minutes ]
    The VAS(visual analog scale) score is a subjective measure for pain. Scores are recorded by making a handwritten mark by the patient on a 10-cm line that represents a continuum between "no pain" and "worst pain." The score will be transferred to a 0-100 index by divided 10 with the distance from the starting point to the written mark (in centimeter) and multiplied by 100. The ANI (Analgesia Nociception Index) score is a 0-100 index derived from heart rate variability which was applied as an objective pain measurement. The larger the index indicated less pain. The correlation of the VAS score and the ANI score will be analyzed to verified the strength of the ANI score in evaluating labor pain during epidural analgesia.


Secondary Outcome Measures :
  1. The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score [ Time Frame: 90 Minutes ]
    Uterine contraction strength was measured by external cardiotocography with a scare from 0-100.The ANI (Analgesia Nociception Index) score is a 0-100 index derived from heart rate variability which was applied as an objective pain measurement. The larger the index indicated less pain. The correlation of the uterine contraction strength and the ANI score will be analyzed to verified if the ANI score changing with related to uterine contraction.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parturients received epidural analgesia
Criteria

Inclusion Criteria:

  • Parturients with gestational age more than 35 weeks
  • Ages between 20 to 50
  • Received epidural analgesia
  • American Society of Anesthesiologists classification I or II.

Exclusion Criteria:

  • 1. Who refused to join the study
  • 2. With a history of arrhythmia
  • 3. American Society of Anesthesiologists (ASA)Classification >= III
  • 4. With a history of cardiovascular, pulmonary, endocrine, neurologic or psychiatric disease
  • 5.Using medications that affecting heart rate
  • 6. Cannot understand the explanation of the study
  • 7. High-risk gestation
  • 8. Known fetal anomaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975816


Contacts
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Contact: Min-Ling Chen, MD +886-910-183-202 u9701401@cmu.edu.tw

Sponsors and Collaborators
Changhua Christian Hospital
Investigators
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Study Director: Shao-Lun Tsao, MD Changhua Christian Hospital, Department of Anesthesiology

Publications:
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Responsible Party: Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03975816     History of Changes
Other Study ID Numbers: ANIpainlesslabor
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individuals participants data for primary outcome measure will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available within 1 year of study completion
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Changhua Christian Hospital:
Analgesia nociception index
Painless labor
epidural analgesia

Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms