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)

Thoracotomy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05944523
• Other study ID #: CananT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Preemptive Analgesia
• Thoracotomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Faculty of Medicine, Ankara University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 in the amount of intraopioid consumption by Nociception Level Index	Up to 24 hours