Relationship Between Analgesia Nociception Index, Anxiety, and Pain in Conscious Hernia Patients Undergoing Combined Spinal Epidural Anesthesia
Sponsor study identifier
observational
24
1 country
1
Study Start
September 25, 2021
Actual (reported)Primary Completion
February 25, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Analgesia Nociception Index can be used to detect noxious stimulation during general anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia procedures in conscious hernia patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2021
Actual (reported)September 22, 2021
Actual (reported)September 25, 2021
Actual (reported)February 25, 2023
Actual (reported)May 31, 2023
Actual (reported)The correlation between ANI and pain (measured with Visual Analog Scale,VAS), ANI and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures
ANI is derived from hear rate variability, ranging from 0-100, bigger number means better analgesic level. Patients undergoing CSEA may experience mid-level anxiety while remaining conscious. The anxiety (VAS-A), pain (VAS), and ANI assessments were conducted at four specific time points.
The changes of ANI, VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T1=after lateral position, T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture)
The correlation between pain (measured with Visual Analog Scale,VAS) and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures
The changes of VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture)
The assessments are conducted in conscious patients under the procedure of Combined spinal epidural anesthesia.
The Anxiety (Visual Analogue Scale for Anxiety), pain (Visual Analogue Scale), and the Analgesia Nociception Index (ANI) assessments are conducted at four specific time points: lateral position, local anesthesia, epidural needle puncture and 2 minutes after puncture.
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Participants with ASA status I or II, aged between 18 and 80 years old, scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA were included in the study. Participants with chronic pain, cardiovascular dysfunction, arrhythmia, dysautonomia, pacemaker usage, medication affecting the autonomic nervous system, contraindications to CSEA, or previous exposure to CSEA or surgery were excluded.
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Guo S, Wen H, Yang L. The Analgesia Nociception Index is More Strongly Associated with Anxiety Than with Pain in Conscious Male Patients Undergoing Hernia Repair Under Combined Spinal-epidural Anaesthesia. Turk J Anaesthesiol Reanim. 2026 Oct 15. doi: 10.4274/TJAR.2026.262544. Online ahead of print.
24 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2021
First Posted
September 22, 2021
Study Start
September 25, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 25, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Last Updated
August 13, 2024
Record last verified: 2024-08
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