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

Labor Pain Clinical Trial

Official title:

Changhua Christian Hospital, Department of Anesthesiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975816
• Other study ID #: ANIpainlesslabor
• Status: Recruiting
• Start date: November 17, 2019
• Est. completion date: August 21, 2023

Study information

• Verified date: August 2021
• Source: Changhua Christian Hospital
• Contact: Min-Ling Chen, MD
• Phone: +886-910-183-202
• Email: u9701401[@]cmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Taiwan	Changhua Christian hospital	Changhua City

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloë PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score	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.	90 minutes
Secondary	The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score	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.	90 Minutes