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)

NCT ID: NCT05944523

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-05-01

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.

Conditions

Erector Spina Plan Block; Preemptive Analgesia; Thoracotomy; Nociception Level Index(NoL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

The group in which preemptive erector spina plane block was applied

Group Type: ACTIVE_COMPARATOR

Erector Spina Plan Block

Intervention Type: PROCEDURE

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.

Group 2

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

Group Type: ACTIVE_COMPARATOR

Erector Spina Plan Block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Canan Tokur

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neslihan Alkış, Prof. Dr.

Role: STUDY_DIRECTOR

Faculty of Medicine, Ankara University

Locations

Faculty of Medicine, Ankara University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CananT

Identifier Type: -

Identifier Source: org_study_id