Effect of ANI on Intraoperative Opioid Consumption

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Analgesia; Nociceptive Pain; Nerve Block

• Study Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: çağdaş baytar, MD; Phone Number: +905542255960; Email: cagdasbaytar31@gmail.com

Study Locations

• Turkey
  • Kozlu
    • Zonguldak, Kozlu, Turkey, 67600
      • Recruiting
      • Zonguldak Bülent Ecevit University Medicine Faculty
      • Contact: Murat Can, prof.dr; Phone Number: +90 372 261 20 15; Email: beuntipfakultesi@beun.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female patients gynecological surgery under general anesthesia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group ANI
Group Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	Effect of ANI monitoring on intraoperative opioid consumption	during the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergence time	time between last suture and extubation	at the end of the surgery
VAS pain scores	pain scores in the recovery unit	during her stay in the recovery unit
duration of stay in recovery room	time between entering and exiting the recovery unit	at the end of the surgery
nausea and vomiting i	incidence of nausea and vomiting in recovery room	during her stay in the recovery unit

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University
• Collaborators: Zeynep Koc

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Analgesia; Analgesia nociception index; Pain monitoring
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: 2021/18-4

Drug and device information, study documents

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