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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539080
• Other study ID #: 20MMHIS210e
• Status: Recruiting
• Start date: August 30, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: January 2023
• Source: Mackay Memorial Hospital
• Contact: Tzu-Chun Wang, MD
• Phone: +886-02-2543-3535
• Email: ff_west[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2023
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia and Analgesia
• Autonomic Nervous System
• EEG
• Laparoscopy
• Nerve Block

Intervention

Procedure:
• transversus abdominis plane block
transversus abdominis plane block group

Locations

Country	Name	City	State
Taiwan	Taitung MacKay memorial hospital	Taitung	Taitung, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Different heart rate variability pattern during laparoscopy	Different heart rate variability pattern in incision and inflation with or without TAP block	6 months