Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block

Recruiting

• Conditions: Anesthesia and Analgesia; EEG; Autonomic Nervous System; Nerve Block; Laparoscopy
• Interventions: Procedure: transversus abdominis plane block

• Registration Number: NCT04539080
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

Heart rate variability(HRV) and electroencephalography(EEG) has been used widely in anesthetic practice nowadays. One of the most dominant applications is the nociception-analgesia balance. Some evidence support that heart rate variability correlates with perioperative stimulation and postoperative pain score. There are some new evidence support EEG correlated with anesthesia depth and analgesic balance. However, the heterogeneity between the studies and interference factors has limited their usage in clinical practice. On the other hand, peripheral nerve block is broadly used as a routine technique with general anesthesia, but few studies discuss the effect on heart rate variability. Our study focuses on the different HRV and EEG patterns of incision and insufflation during laparoscopic surgery with general anesthesia. Furthermore, we measure the effect of transversus abdominis plane nerve block to heart rate variability during surgery. By this comparison, we can discuss the influences of somatic stimulation, visceral stimulation, and pneumoperitoneum to heart rate variability, and then improve the accuracy of HRV-based nociception-analgesia monitors.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-30
• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-08-30
• Study First Posted: 2020-09-04
• Primary Completion: 2021-02-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ≥20 years of age male or female
• American Society of Anesthesiologists (ASA) physical status classification I or II
• capacity to give informed consent

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Exclusion Criteria

• major cardiovascular and cerebral vascular disease, arrhythmia, respiratory disease, diabetes mellitus with evidence of neuropathy; ASA physical status classification III or greater; a documented or self-reported history of chronic pain; acute or chronic opioid analgesic use; dysautonomia; and intraoperative muscarinic anticholinergic administration during the time of monitoring.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-operative transversus abdominis plane block	transversus abdominis plane block	The group with transversus abdominis plane block before laparoscopic surgeries with a standard pain control protocol

Primary Outcome Measures

Name	Time	Method
Different heart rate variability pattern during laparoscopy	6 months	Different heart rate variability pattern in incision and inflation with or without TAP block

Trial Locations

Locations (1)

Taitung MacKay memorial hospital; 🇨🇳 Taitung, Taitung, Taiwan, Taiwan