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)

Sponsor

Ankara University (Other)

Overall Status

Completed

CT.gov ID

NCT05944523

Collaborator

The Scientific and Technological Research Council of Turkey (Other)

Enrollment

Location

Arms

15.9

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erector Spina Plan Block Preemptive Analgesia Thoracotomy Nociception Level Index(NoL)	Procedure: Erector Spina Plan Block	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 The group in which preemptive erector spina plane block was applied	Procedure: Erector Spina Plan Block Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.
Active Comparator: Group 2 The group in which the end of the surgery was applied to the erector spina plane block	Procedure: Erector Spina Plan Block Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.

Arm

Intervention/Treatment

Active Comparator: Group 1

The group in which preemptive erector spina plane block was applied

Procedure: Erector Spina Plan Block

Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.

Active Comparator: Group 2

The group in which the end of the surgery was applied to the erector spina plane block

Procedure: Erector Spina Plan Block

Outcome Measures

Primary Outcome Measures

The value of Nociception Level Index (NoL) in both preemptive and postoperative groups [Up to 24 hours]
We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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