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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKocaeli University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients undergo elective thoracotomy surgery

ASA physical status I-III

Disqualifiers

Spinal deformities

BMI>35

Patiens <50 kg

Allergies to study medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paravertebral block

    Procedure/Surgery

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

  • Erector spiane plane block

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ESP GroupActive comparator 1 intervention
Group B: PVB GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remifentanil consumption

Total amount of remifentanil used during the surgery (mg)

Time frame
Intraoperative
2

NRS Scores

Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)

Time frame
Postoperative 1st, 6th, 12th and 24th hours
3

Morphine consumption

Amount of morphine in the postoperative period (mg)

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

Secondary outcomes

1

Rescue analgesic

The use of rescue analgesic

Time frame
Postoperative 1st, 6th, 12th and 24th hours
2

Nausea and vomiting

If the patient had nausea or vomiting, it will be recorded.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.