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

NCT ID: NCT03975816

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-17
• Study Completion Date: 2023-08-21

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.

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.

Conditions

Labor Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Analgesia nociception index

Monitor the maternity with Analgesia nociception index

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shao-Lun Tsao, MD

Role: STUDY_DIRECTOR

Changhua Christian Hospital, Department of Anesthesiology

Locations

Changhua Christian hospital

Changhua, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Min-Ling Chen, MD

Role: CONTACT

u9701401@cmu.edu.tw

+886-910-183-202

Facility Contacts

Min-Ling Chen, MD

Role: primary

u9701401@cmu.edu.tw

+886-910-183-202

Shao-Lun Tsao, MD

Role: backup

117223@cch.org.tw

+886-983-901-710

References

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.

Reference Type: BACKGROUND

PMID: 22360936 (View on PubMed)

Other Identifiers

ANIpainlesslabor

Identifier Type: -

Identifier Source: org_study_id