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

NCT ID: NCT06507293

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESP Group

Patients who will receive erector spinae plane block

Group Type: ACTIVE_COMPARATOR

Erector spiane plane block

Intervention Type: PROCEDURE

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

PVB Group

Patients who will receive paravertebral block

Group Type: ACTIVE_COMPARATOR

Paravertebral block

Intervention Type: PROCEDURE

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

Interventions

Paravertebral block

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Hadi Ufuk Yörükoğlu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadi Ufuk Yörükoğlu

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University, Department of Anesthesiology and Reanimation

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hadi Ufuk Yörükoğlu

Role: CONTACT

ufukyorukoglu@gmail.com

+902623038248

Facility Contacts

Hadi Ufuk Yörükoğlu, MD

Role: primary

ufukyorukoglu@gmail.com

+905372439215

Other Identifiers

KAD-FR-01

Identifier Type: -

Identifier Source: org_study_id