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Completed

NCT Number: NCT05944523

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)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Ankara University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65 years
  • ASA classification <4
  • No history of allergy or hypersensitivity to the drugs we use throughout the procedure
  • BMI ≤ 35
  • 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
  • Undergo surgery again during the postoperative follow-up period for any reason

Treatment and study plan

erector spina plan block

Procedure

Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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