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

Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06507293
Enrollment
60
Registered
2024-07-18
Start date
2024-08-01
Completion date
2025-12-01
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Postoperative Pain

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.

Interventions

PROCEDUREParavertebral block

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

PROCEDUREErector 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Remifentanil consumptionIntraoperativeTotal amount of remifentanil used during the surgery (mg)
NRS ScoresPostoperative 1st, 6th, 12th and 24th hoursNumeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)
Morphine consumptionPostoperative 1st, 6th, 12th and 24th hoursAmount of morphine in the postoperative period (mg)

Secondary

MeasureTime frameDescription
Rescue analgesicPostoperative 1st, 6th, 12th and 24th hoursThe use of rescue analgesic
Nausea and vomitingPostoperative 1st, 6th, 12th and 24th hoursIf the patient had nausea or vomiting, it will be recorded.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHadi Ufuk Yörükoğlu
ufukyorukoglu@gmail.com+902623038248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026