NCT06507293 Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index
| NCT ID | NCT06507293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kocaeli University |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Hadi Ufuk Yörükoğlu
PRINCIPAL INVESTIGATOR
Kocaeli University, Department of Anesthesiology and Reanimation
Frequently Asked Questions
Who can join the NCT06507293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06507293 currently recruiting?
Yes, NCT06507293 is actively recruiting participants. Contact the research team at ufukyorukoglu@gmail.com for enrollment information.
Where is the NCT06507293 trial being conducted?
This trial is being conducted at Kocaeli, Turkey (Türkiye).
Who is sponsoring the NCT06507293 clinical trial?
NCT06507293 is sponsored by Kocaeli University. The principal investigator is Hadi Ufuk Yörükoğlu at Kocaeli University, Department of Anesthesiology and Reanimation. The trial plans to enroll 60 participants.