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Clinical Trials/NCT06507293
NCT06507293
Recruiting
Not Applicable

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

Kocaeli University1 site in 1 country60 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Kocaeli University
Enrollment
60
Locations
1
Primary Endpoint
Remifentanil consumption
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
December 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadi Ufuk Yörükoğlu

Principal investigator

Kocaeli University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Spinal deformities
  • Patiens \<50 kg
  • Allergies to study medications

Outcomes

Primary Outcomes

Remifentanil consumption

Time Frame: Intraoperative

Total amount of remifentanil used during the surgery (mg)

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)

Morphine consumption

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

Amount of morphine in the postoperative period (mg)

Secondary Outcomes

  • Rescue analgesic(Postoperative 1st, 6th, 12th and 24th hours)
  • Nausea and vomiting(Postoperative 1st, 6th, 12th and 24th hours)

Study Sites (1)

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