Postoperative PainNCT06507293
Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index
A study testing Paravertebral block and Erector spiane plane block in people with Postoperative Pain and Opioid Use, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Opioid Use
- What is being tested?
- Paravertebral block and Erector spiane plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergo elective thoracotomy surgery
- ASA physical status I-III
Who cannot join
- Spinal deformities
- BMI>35
- Patiens <50 kg
- Allergies to study medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
Kocaeli, 41350
Hadi Ufuk Yörükoğlu, MD, +905372439215, ufukyorukoglu@gmail.com
About this study
Official title: Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy
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
- Being tested
- Paravertebral block, Erector spiane plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockProcedure or surgery
Before the general anesthesia induction, paravertebral block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.
Erector spiane plane blockProcedure or surgery
Before the general anesthesia induction, erector spinae plane block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| ESP Group | Active comparator | Patients who will receive erector spinae plane block Receives: Procedure: Erector spiane plane block |
| PVB Group | Active comparator | Patients who will receive paravertebral block Receives: Procedure: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption
Total amount of remifentanil used during the surgery (mg)
Measured: Intraoperative
NRS Scores
Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)
Measured: Postoperative 1st, 6th, 12th and 24th hours
Morphine consumption
Amount of morphine in the postoperative period (mg)
Measured: Postoperative 1st, 6th, 12th and 24th hours
Secondary outcomes (2)
Rescue analgesic
The use of rescue analgesic
Measured: Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting
If the patient had nausea or vomiting, it will be recorded.
Measured: Postoperative 1st, 6th, 12th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Ufuk Yörükoğlu, Kocaeli University
- Investigators
- Hadi Ufuk Yörükoğlu, Principal investigator, Kocaeli University, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507293
- Sponsor's protocol ID
- KAD-FR-01
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy
- ClinicalTrials.gov ID
- NCT06507293
- Acronym / sponsor ID
- KAD-FR-01
- Conditions
- Postoperative Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Group | Active comparator | Procedure: Erector spiane plane blockPatients who will receive erector spinae plane block |
| PVB Group | Active comparator | Procedure: Paravertebral blockPatients who will receive paravertebral block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergo elective thoracotomy surgery
- ASA physical status I-III
Key exclusion criteria (4 listed)
- Spinal deformities
- BMI>35
- Patiens <50 kg
- Allergies to study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral blockBefore the general anesthesia induction, paravertebral block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound. | Procedure or surgery | PVB Group |
| Erector spiane plane blockBefore the general anesthesia induction, erector spinae plane block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound. | Procedure or surgery | ESP Group |
Primary outcome
Remifentanil consumption
Time frame: Intraoperative
Total amount of remifentanil used during the surgery (mg)
NRS Scores
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)
Morphine consumption
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Amount of morphine in the postoperative period (mg)
2 secondary outcomes
Rescue analgesic
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadi Ufuk Yörükoğlu principal investigator
Kocaeli University, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block and Erector spiane plane block in people with Postoperative Pain and Opioid Use, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadi Ufuk Yörükoğlu (+902623038248, ufukyorukoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil consumption (time frame: Intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.