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Clinical Trials/NCT05944523
NCT05944523
Completed
Not Applicable

Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)

Ankara University1 site in 1 country52 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erector Spina Plan Block
Sponsor
Ankara University
Enrollment
52
Locations
1
Primary Endpoint
The value of Nociception Level Index (NoL) in both preemptive and postoperative groups
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.

Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.

In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
May 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Canan Tokur

Research Assistant

Ankara University

Eligibility Criteria

Inclusion Criteria

  • Age between 18-65 years
  • ASA classification \<4
  • No history of allergy or hypersensitivity to the drugs we use throughout the procedure
  • No history of neuropathy
  • Surgeries other than emergency surgery
  • Volunteer for the study
  • No presence of infection at the injection site
  • No any pyschiatric disease that would prevent the evaluation of the pain score

Exclusion Criteria

  • Under the age of 18 or over the age of 65
  • ASA classification ≥ 4
  • History of allergy or hypersensitivity to the drugs we use throughout the procedure
  • BMI \> 35
  • History of neuropathy
  • Undergoing emergency surgery
  • Not be a volunteer for the study
  • Presence of infection at the injection site
  • Having a pyschiatric disease that would prevent the evaluation of the pain score
  • Pregnancy

Outcomes

Primary Outcomes

The value of Nociception Level Index (NoL) in both preemptive and postoperative groups

Time Frame: Up to 24 hours

We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index

Study Sites (1)

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