Clinical trial NCT03975816: The Application of Analgesia Nociception Index as an Objective Labor Pain Assessment During Epidural Analgesia
Official title: Changhua Christian Hospital, Department of Anesthesiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor Pain
Keywords: Analgesia nociception index
Painless labor
epidural analgesia
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parturients received epidural analgesia

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.

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

Primary outcomes:
measure: The correlation of subjective pain measurement by the VAS score and objective pain measurement by the ANI(Analgesia Nociception Index) score
timeFrame: 90 minutes
Secondary outcomes:
measure: The correlation of uterine contraction strength measured by cardiotocography and the ANI (Analgesia Nociception Index) score
timeFrame: 90 Minutes
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Changhua Christian hospital
Study officials:
affiliation: Changhua Christian Hospital, Department of Anesthesiology
name: Shao-Lun Tsao, MD
role: STUDY_DIRECTOR
References:
citation: 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.