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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)

Primary Purpose

Erector Spina Plan Block, Preemptive Analgesia, Thoracotomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spina Plan Block
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spina Plan Block focused on measuring preemptive analgesia, erector spina plan block, nociception level (NoL) index, thoracotomy, opioid consumption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine, Ankara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

The group in which preemptive erector spina plane block was applied

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 12, 2023
Sponsor
Ankara University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05944523
Brief 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)
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
The group in which preemptive erector spina plane block was applied
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
The group in which the end of the surgery was applied to the erector spina plane block
Intervention Type
Procedure
Intervention Name(s)
Erector Spina Plan Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
The value of Nociception Level Index (NoL) in both preemptive and postoperative groups
Description
We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan Alkış, Prof. Dr.
Organizational Affiliation
Faculty of Medicine, Ankara University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Ankara University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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)

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