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NCT Number: NCT06507293

Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index

Thoracotomy is among the most painful surgical procedures and can cause severe pain with a high incidence. Inadequate treatment of acute postoperative pain may lead to undesired complications. Paravertebral block (PVB) is an effective technique that provides adequate analgesia in thoracic surgeries. However, it is an advanced technique with potential complication risks. Erector spinae plane block (ESPB) is a relatively new and considered as a safer technique that provides comparable analgesia. However, the results are controversial and there are few studies that compares the effect of these blocks in thoracic surgeries. As well as the undesired effects of inadequate pain management, high doses of perioperative opioid usage may contribute to the development of dose-dependent long-term adverse events. Hemodynamic parameters are generally used to determine the intraoperative need for opioids in patients; however, hemodynamic parameters are not standardized and they do not provide a clear assessment. The Nociception Level (NoL) index is generated from five different parameters (heart rate, heart Rrate variability, photo-plethysmographic waveform amplitude, skin conductance level, number of skin conductance fluctuations, and their time derivatives) using a finger probe and is a promising monitoring technique. Selecting an effective analgesia method and determining the appropriate dose of opioids using NoL monitoring can reduce perioperative and postoperative complications and shorten hospital stays, allowing patients to return to daily life sooner. Additionally, preventing chronic pain syndromes that may develop in patients with inadequate analgesia, personalizing each patient's analgesia level, reducing healthcare costs, and improving quality of life can be achieved. The data from this study can demonstrate the analgesic efficacy of simpler regional anesthesia techniques, contributing to the widespread adoption of regional anesthesia applications, which is a crucial step in multimodal analgesia, thereby ensuring more effective pain management for surgical patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hadi Ufuk Yörükoğlu, MD

CONTACT

[email protected]

+905372439215

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergo elective thoracotomy surgery
  • ASA physical status I-III

Exclusion criteria

  • Spinal deformities
  • BMI>35
  • Patiens <50 kg
  • Allergies to study medications

Treatment and study plan

paravertebral block

Procedure

Before the general anesthesia induction, paravertebral block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.

Erector spiane plane block

Procedure

Before the general anesthesia induction, erector spinae plane block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.

Primary outcomes

  1. Remifentanil consumption

    Time frame: Intraoperative

    Total amount of remifentanil used during the surgery (mg)

  2. NRS Scores

    Time frame: Postoperative 1st, 6th, 12th and 24th hours

    Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)

  3. Morphine consumption

    Time frame: Postoperative 1st, 6th, 12th and 24th hours

    Amount of morphine in the postoperative period (mg)

Secondary outcomes

  1. Rescue analgesic

    Time frame: Postoperative 1st, 6th, 12th and 24th hours

    The use of rescue analgesic

  2. Nausea and vomiting

    Time frame: Postoperative 1st, 6th, 12th and 24th hours

    If the patient had nausea or vomiting, it will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Hadi Ufuk Yörükoğlu

CONTACT

[email protected]

+902623038248

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Sep 4, 2025

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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