Effect of ANI on Intraoperative Opioid Consumption

Pain Clinical Trial

Official title:

Intraoperative Analgesia Management in Gynecological Surgery With Erector Spinae Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106452
• Other study ID #: 2021/18-4
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2021
• Source: Zonguldak Bulent Ecevit University
• Contact: çagdas baytar, MD
• Phone: +905542255960
• Email: cagdasbaytar31[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Analgesia
• Nerve Block
• Nociceptive Pain
• Pain

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu

Sponsors (2)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University	Zeynep Koc

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative opioid consumption	Effect of ANI monitoring on intraoperative opioid consumption	during the surgery
Secondary	emergence time	time between last suture and extubation	at the end of the surgery
Secondary	VAS pain scores	pain scores in the recovery unit	during her stay in the recovery unit
Secondary	duration of stay in recovery room	time between entering and exiting the recovery unit	at the end of the surgery
Secondary	nausea and vomiting i	incidence of nausea and vomiting in recovery room	during her stay in the recovery unit