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

• Sponsor: Changhua Christian Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03975816
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 45.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Changhua Christian Hospital, Department of Anesthesiology
• Actual Study Start Date: Nov 17, 2019
• Anticipated Primary Completion Date: Aug 21, 2022
• Anticipated Study Completion Date: Aug 21, 2023

Outcome Measures

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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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
• 1. With a history of arrhythmia
• 1. American Society of Anesthesiologists (ASA)Classification >= III
• 1. With a history of cardiovascular, pulmonary, endocrine, neurologic or psychiatric disease

• 5.Using medications that affecting heart rate

• 1. Cannot understand the explanation of the study
• 1. High-risk gestation
• 1. Known fetal anomaly

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhua Christian hospital	Changhua City		Taiwan	500

Sponsors and Collaborators

• Changhua Christian Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Changhua Christian Hospital
• ClinicalTrials.gov Identifier: NCT03975816
• Other Study ID Numbers: ANIpainlesslabor
• First Posted: Jun 5, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Labor Pain

Study Results

No Results Posted as of Aug 5, 2021