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

NCT03975816 | Unknown

• 1 other identifier: ANIpainlesslabor
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Analgesia nociception index; Painless labor; epidural analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score

  90 Minutes

Interventions

Analgesia nociception index DEVICE

Monitor the maternity with Analgesia nociception index

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Parturients received epidural analgesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian hospital

Changhua, 500, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 22360936 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shao-Lun Tsao, MD

  Changhua Christian Hospital, Department of Anesthesiology

  STUDY DIRECTOR

Central Study Contacts

Min-Ling Chen, MD

CONTACT

+886-910-183-202; u9701401@cmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: June 5, 2019
• Study Start: November 17, 2019
• Primary Completion: August 21, 2022
• Study Completion: August 21, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

TW (1)