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

NCT06507293 | Recruiting

• 1 other identifier: KAD-FR-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Opioid Use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Rescue analgesic

  Postoperative 1st, 6th, 12th and 24th hours

• Nausea and vomiting

  Postoperative 1st, 6th, 12th and 24th hours

Study Arms (2)

ESP Group

ACTIVE COMPARATOR

Patients who will receive erector spinae plane block

Procedure: Erector spiane plane block

PVB Group

ACTIVE COMPARATOR

Patients who will receive paravertebral block

Procedure: Paravertebral block

Interventions

Paravertebral block PROCEDURE

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

PVB Group

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.

ESP Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hadi Ufuk Yörükoğlu

  Kocaeli University, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadi Ufuk Yörükoğlu

CONTACT

+902623038248; ufukyorukoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)