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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia nociception index | Device | Monitor the maternity with Analgesia nociception index |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Parturients received epidural analgesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Ling Chen, MD | Contact | +886-910-183-202 | u9701401@cmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Shao-Lun Tsao, MD | Changhua Christian Hospital, Department of Anesthesiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian hospital | Recruiting | Changhua | 500 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22360936 | Background | 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. |
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De-identified individuals participants data for primary outcome measure will be made available
data will be available within 1 year of study completion
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 90 Minutes |