Clinical trial NCT06507293: Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index
Official title: Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Remifentanil consumption
timeFrame: Intraoperative
measure: NRS Scores
timeFrame: Postoperative 1st, 6th, 12th and 24th hours
measure: Morphine consumption
timeFrame: Postoperative 1st, 6th, 12th and 24th hours
Secondary outcomes:
measure: Rescue analgesic
timeFrame: Postoperative 1st, 6th, 12th and 24th hours
measure: Nausea and vomiting
timeFrame: Postoperative 1st, 6th, 12th and 24th hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University, Department of Anesthesiology and Reanimation
name: Hadi Ufuk Yörükoğlu
role: PRINCIPAL_INVESTIGATOR
References: