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

Changhua Christian Hospital, Department of Anesthesiology

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Min-Ling Chen, MD; Phone Number: +886-910-183-202; Email: u9701401@cmu.edu.tw

Study Locations

• Taiwan
  • Changhua City, Taiwan, 500
    • Recruiting
    • Changhua Christian Hospital
    • Contact: Min-Ling Chen, MD; Phone Number: +886-910-183-202; Email: u9701401@cmu.edu.tw
    • Contact: Shao-Lun Tsao, MD; Phone Number: +886-983-901-710; Email: 117223@cch.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Parturients received epidural analgesia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Investigators: Study Director: Shao-Lun Tsao, MD, Changhua Christian Hospital, Department of Anesthesiology

Publications and helpful links

General Publications

• Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2019
• Primary Completion (ANTICIPATED): August 21, 2022
• Study Completion (ANTICIPATED): August 21, 2023

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: epidural analgesia; Analgesia nociception index; Painless labor
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: ANIpainlesslabor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individuals participants data for primary outcome measure will be made available
• IPD Sharing Time Frame: data will be available within 1 year of study completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No