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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Procedure: Erector spiane plane block; Procedure: Paravertebral block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadi Ufuk Yörükoğlu; Phone Number: +902623038248; Email: ufukyorukoglu@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kocaeli, Turkey (Türkiye), 41350
    • Recruiting
    • Kocaeli University
    • Contact: Hadi Ufuk Yörükoğlu, MD; Phone Number: +905372439215; Email: ufukyorukoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESP Group; Patients who will receive erector spinae plane block	Procedure: Erector spiane plane block; Before the general anesthesia induction, erector spinae plane block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.
Active Comparator: PVB Group; Patients who will receive paravertebral block	Procedure: Paravertebral block; Before the general anesthesia induction, paravertebral block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil consumption	Total amount of remifentanil used during the surgery (mg)	Intraoperative
NRS Scores	Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)	Postoperative 1st, 6th, 12th and 24th hours
Morphine consumption	Amount of morphine in the postoperative period (mg)	Postoperative 1st, 6th, 12th and 24th hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic	The use of rescue analgesic	Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting	If the patient had nausea or vomiting, it will be recorded.	Postoperative 1st, 6th, 12th and 24th hours

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Hadi Ufuk Yörükoğlu, Kocaeli University, Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: KAD-FR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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