Clinical trial NCT05944523: Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
Official title: Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spina Plan Block
Preemptive Analgesia
Thoracotomy
Nociception Level Index(NoL)
Keywords: preemptive analgesia
erector spina plan block
nociception level (NoL) index
thoracotomy
opioid consumption
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-07-13
Enrollment: 52
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: The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.

Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.

In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* ASA classification \<4
* No history of allergy or hypersensitivity to the drugs we use throughout the procedure
* BMI ≤ 35
* No history of neuropathy
* Surgeries other than emergency surgery
* Volunteer for the study
* No presence of infection at the injection site
* No any pyschiatric disease that would prevent the evaluation of the pain score

Exclusion Criteria:

* Under the age of 18 or over the age of 65
* ASA classification ≥ 4
* History of allergy or hypersensitivity to the drugs we use throughout the procedure
* BMI \> 35
* History of neuropathy
* Undergoing emergency surgery
* Not be a volunteer for the study
* Presence of infection at the injection site
* Having a pyschiatric disease that would prevent the evaluation of the pain score
* Pregnancy
* Undergo surgery again during the postoperative follow-up period for any reason

Primary outcomes:
measure: The value of Nociception Level Index (NoL) in both preemptive and postoperative groups
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Medicine, Ankara University
Study officials:
affiliation: Faculty of Medicine, Ankara University
name: Neslihan Alkış, Prof. Dr.
role: STUDY_DIRECTOR
References: