Autonomic Nervous SystemNCT04539080
Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block
An observational study of Autonomic Nervous System and Nerve Block, run by Mackay Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System, Nerve Block, Laparoscopy
- What is being tested?
- transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2020to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: scheduled to undergo general anesthesia for laparoscopic surgery (cholecystectomy or appendectomy) at Taitung MacKay memorial hospital
Who may be able to join
- ≥20 years of age male or female
- American Society of Anesthesiologists (ASA) physical status classification I or II
- capacity to give informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taitung MacKay memorial hospital
Taitung, Taitung, Taiwan
Tzu-Chun Wang, MD, ff_west@hotmail.com
Tzu-Chun Wang, MD
About this study
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.
- Being tested
- transversus abdominis plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockProcedure or surgery
transversus abdominis plane block group
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative transversus abdominis plane block | The group with transversus abdominis plane block before laparoscopic surgeries with a standard pain control protocol Receives: Procedure: transversus abdominis plane block | |
| Traditional pain control group | The group with a standard pain control protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different heart rate variability pattern during laparoscopy
Different heart rate variability pattern in incision and inflation with or without TAP block
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start30 Aug 2020
- Primary completion28 Feb 2021
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu-Chun Wang, MD, Principal investigator, Taitung Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539080
- Sponsor's protocol ID
- 20MMHIS210e
- Status last verified
- Jan 2023
- First submitted
- 30 Aug 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TC, Kuo YE, Kuo TBJ, Yang CCH. Frontal Electroencephalogram Phase-Amplitude Coupling Reflects Nociception and the Analgesic Effect of Transversus Abdominis Plane Block in Laparoscopic Surgery. Anesthesiology. 2026 Apr 1;144(4):837-852. doi: 10.1097/ALN.0000000000005924. Epub 2026 Jan 20.
PubMed 41557599Wang TC, Li WY, Lai JC, Kuo TBJ, Yang CCH. Nociception Effect on Frontal Electroencephalogram Waveform and Phase-Amplitude Coupling in Laparoscopic Surgery. Anesth Analg. 2024 May 1;138(5):1070-1080. doi: 10.1213/ANE.0000000000006609. Epub 2023 Jul 10.
PubMed 37428681
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT04539080
- Acronym / sponsor ID
- 20MMHIS210e
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative transversus abdominis plane block | – | Procedure: transversus abdominis plane blockThe group with transversus abdominis plane block before laparoscopic surgeries with a standard pain control protocol |
| Traditional pain control group | – | –The group with a standard pain control protocol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- scheduled to undergo general anesthesia for laparoscopic surgery (cholecystectomy or appendectomy) at Taitung MacKay memorial hospital
Key inclusion criteria (3 listed)
- ≥20 years of age male or female
- American Society of Anesthesiologists (ASA) physical status classification I or II
- capacity to give informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transversus abdominis plane blocktransversus abdominis plane block group | Procedure or surgery | Pre-operative transversus abdominis plane block |
Primary outcome
Different heart rate variability pattern during laparoscopy
Time frame: 6 months
Different heart rate variability pattern in incision and inflation with or without TAP block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 41557599Wang TC, Kuo YE, Kuo TBJ, Yang CCH. Frontal Electroencephalogram Phase-Amplitude Coupling Reflects Nociception and the Analgesic Effect of Transversus Abdominis Plane Block in Laparoscopic Surgery. Anesthesiology. 2026 Apr 1;144(4):837-852. doi: 10.1097/ALN.0000000000005924. Epub 2026 Jan 20.
- Derived from this study: PubMed 37428681Wang TC, Li WY, Lai JC, Kuo TBJ, Yang CCH. Nociception Effect on Frontal Electroencephalogram Waveform and Phase-Amplitude Coupling in Laparoscopic Surgery. Anesth Analg. 2024 May 1;138(5):1070-1080. doi: 10.1213/ANE.0000000000006609. Epub 2023 Jul 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Chun Wang, MD principal investigator
Taitung Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System and Nerve Block, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Chun Wang, MD (+886-02-2543-3535, ff_west@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different heart rate variability pattern during laparoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.