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)

NCT05944523 | Completed

• 1 other identifier: CananT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Keywords

preemptive analgesia; erector spina plan block; nociception level (NoL) index; thoracotomy; opioid consumption

Outcome Measures

Primary Outcomes (1)

• The value of Nociception Level Index (NoL) in both preemptive and postoperative groups

  We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index

  Up to 24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

The group in which preemptive erector spina plane block was applied

Procedure: Erector Spina Plan Block

Group 2

ACTIVE COMPARATOR

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

Procedure: Erector Spina Plan Block

Interventions

Erector Spina Plan Block 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 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Faculty of Medicine, Ankara University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erythema Multiforme

Condition Hierarchy (Ancestors)

Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Study Officials

• Neslihan Alkış, Prof. Dr.

  Faculty of Medicine, Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

TU (1)