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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopy; Anesthesia and Analgesia; Autonomic Nervous System; Nerve Block; EEG
• Intervention / Treatment: Procedure: transversus abdominis plane block

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Tzu-Chun Wang, MD; Phone Number: +886-02-2543-3535; Email: ff_west@hotmail.com

Study Locations

• Taiwan
  • Taitung, Taiwan
    • Taitung, Taitung, Taiwan, Taiwan
      • Recruiting
      • Taitung MacKay Memorial Hospital
      • Contact: Tzu-Chun Wang, MD; Email: ff_west@hotmail.com
      • Principal Investigator: Tzu-Chun Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

scheduled to undergo general anesthesia for laparoscopic surgery (cholecystectomy or appendectomy) at Taitung MacKay memorial hospital

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-operative transversus abdominis plane block; The group with transversus abdominis plane block before laparoscopic surgeries with a standard pain control protocol	Procedure: transversus abdominis plane block; transversus abdominis plane block group
Traditional pain control group; The group with a standard pain control protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Different heart rate variability pattern during laparoscopy	Different heart rate variability pattern in incision and inflation with or without TAP block	6 months

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Tzu-Chun Wang, MD, Taitung MacKay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20MMHIS210e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No