NCT06689449

Brief Summary

In this study, our iş to compare effect of erector spinae plan block(ESP), paravertebral block(PVB) and mid-point transverse process to pleura block(MTP) on perioperative pain measured with analgesia nociceptive index monitor on video-assisted thoracoscopic surgery.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Nov 2024Oct 2026

First Submitted

Initial submission to the registry

November 13, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

November 13, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

video assisted thoracic surgeryerector spinae plan blockparavertebral blockmid-point transverse process to pleura blockanalgesia nosiseption index

Outcome Measures

Primary Outcomes (1)

  • Effective analgesia control in patients with Analgesia Nociception Index(ANI)

    With Analgesia Nociception Index (ANI), it is advantageous to evaluate the objective findings measuring parasympathetic system activity. ANI is a monitor that can be measured continuously and non-invasively. It measures parasympathetic tone - based on electrocardiography - by analyzing minimal changes in heart rate that occur under anesthesia, in the early stages of awakening, and in each respiratory cycle of awake patients. A value between 0-100 is obtained, Values between 50 and 70 indicate good analgesia control. According to studies on ANI, the patient feels pain below 50. If it is above 70, it means that more analgesia is provided. It is thought that pain control will be more effective with these objective data.

    intraoperative

Secondary Outcomes (1)

  • Visual analog scale

    ıntraoperative and postoperative 24 hour

Study Arms (3)

erector spinae plan block group

The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signs before and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and an erector spinae plane block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.

paravertebral block group

The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signs before and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and a paravertebral block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.

mid-point transverse process to pleura block group

The patient will be monitored with routine monitoring and ANI under operating room conditions. VAS values and vital signsbefore and after peripheral nerve block will be recorded. Patients will be placed in the lateral position and a mid-point transverse process to pleura block will be applied under USG guidance by an experienced anesthesiologist. Surgery will be allowed 30 minutes after the block is performed.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA group 2-3-4 patients older than 18 years of age who will under go video assisted thoracic surgery

You may qualify if:

  • Patient over the age of 18 under the 80 Who will undergo video assisted thoracic surgery -ASA group 2-3-4.
  • Patients without opioid addiction.
  • Patients without allergies.
  • Patients without psychiatric disorder.
  • Patients without arrhymia and beta-blocker use.
  • Patients without contraindications for peripheral blocks.

You may not qualify if:

  • Patients under age of 18
  • Patients undergo surgery under general anesthesia
  • Patients undergo emergency surgery
  • Patients allergic to local anesthesia
  • Patients wit bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep aksu

Kayseri, Kayseri̇, 38039, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical Professor.Recep AKSU

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 14, 2024

Study Start

November 20, 2024

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations