AnalgesiaNCT05106452
Effect of ANI on Intraoperative Opioid Consumption
An observational study of Analgesia and Nociceptive Pain, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Nociceptive Pain, Nerve Block
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2021to 1 May 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female patients gynecological surgery under general anesthesia
Who may be able to join
- ASA I-II-III risk group
- Patients who underwent gynecological surgery under general anesthesia, who underwent erector spina block, and whose pain was followed by analgesia nociception index or conventional methods for intraoperative pain monitoring
- Patients whose informed consent was read and consent was obtained from them and their guardians
Who cannot join
- cardiac rhythm disorder
- central-autonomic nervous system disease
- neuropsychiatric disease
- receiving opioid therapy
- Use of drugs that will affect cardiac autonomic regulation
- Known allergy to the drugs to be applied
Show all 9Show fewer
- Contraindicated for ESP block
- Patients who do not agree to participate in the study will not be included in the study.
- Patients who were administered drugs to stabilize the patient's hemodynamics during the operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
Murat Can, prof.dr, +90 372 261 20 15, beuntipfakultesi@beun.edu.tr
About this study
Official title: Intraoperative Analgesia Management in Gynecological Surgery With Erector Spinae Block
The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia.
- Conditions
- Analgesia, Nociceptive Pain, Nerve Block, Pain
- Keywords
- Analgesia nociception index, Pain monitoring, Analgesia
- Medical subject headings
- Agnosia, Nociceptive Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group ANI | Not described | |
| Group Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative opioid consumption
Effect of ANI monitoring on intraoperative opioid consumption
Measured: during the surgery
Secondary outcomes (4)
emergence time
time between last suture and extubation
Measured: at the end of the surgery
VAS pain scores
pain scores in the recovery unit
Measured: during her stay in the recovery unit
duration of stay in recovery room
time between entering and exiting the recovery unit
Measured: at the end of the surgery
nausea and vomiting i
incidence of nausea and vomiting in recovery room
Measured: during her stay in the recovery unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start20 Oct 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Collaborators
- Zeynep Koc
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106452
- Sponsor's protocol ID
- 2021/18-4
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koc Z, Baytar C, Bollucuoglu K, Koksal BG, Okyay RD, Piskin O, Ayoglu H. Intraoperative analgesia management by monitoring the analgesia nociception index in gynecological surgeries involving erector spinae plane block: a randomized controlled study. J Clin Monit Comput. 2025 Dec;39(6):1185-1191. doi: 10.1007/s10877-025-01330-x. Epub 2025 Jul 15.
PubMed 40663304
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Analgesia Management in Gynecological Surgery With Erector Spinae Block
- ClinicalTrials.gov ID
- NCT05106452
- Acronym / sponsor ID
- 2021/18-4
- Conditions
- Analgesia, Nociceptive Pain, Nerve Block, Pain
- Keywords
- Analgesia nociception index, Pain monitoring, Analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Collaborators
- Zeynep Koc
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ANI | – | – |
| Group Control | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female patients gynecological surgery under general anesthesia
Key inclusion criteria (3 listed)
- ASA I-II-III risk group
- Patients who underwent gynecological surgery under general anesthesia, who underwent erector spina block, and whose pain was followed by analgesia nociception index or conventional methods for intraoperative pain monitoring
- Patients whose informed consent was read and consent was obtained from them and their guardians
Key exclusion criteria (9 listed)
- cardiac rhythm disorder
- central-autonomic nervous system disease
- neuropsychiatric disease
- receiving opioid therapy
- Use of drugs that will affect cardiac autonomic regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraoperative opioid consumption
Time frame: during the surgery
Effect of ANI monitoring on intraoperative opioid consumption
4 secondary outcomes
emergence time
Time frame: at the end of the surgery
VAS pain scores
Time frame: during her stay in the recovery unit
duration of stay in recovery room
Time frame: at the end of the surgery
nausea and vomiting i
Time frame: during her stay in the recovery unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Derived from this study: PubMed 40663304Koc Z, Baytar C, Bollucuoglu K, Koksal BG, Okyay RD, Piskin O, Ayoglu H. Intraoperative analgesia management by monitoring the analgesia nociception index in gynecological surgeries involving erector spinae plane block: a randomized controlled study. J Clin Monit Comput. 2025 Dec;39(6):1185-1191. doi: 10.1007/s10877-025-01330-x. Epub 2025 Jul 15.
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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.
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 Analgesia and Nociceptive Pain, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 9 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 11 Nov 2021. 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 Turkey (Türkiye). 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 çağdaş baytar, MD (+905542255960, cagdasbaytar31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative opioid consumption (time frame: during the surgery). 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 NCT05106452, which also lists 1 linked publication.
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 11 Nov 2021.