NCT06778161

Brief Summary

This study aims to compare the postoperative analgesic efficacy of ultrasound-guided erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) in patients undergoing thoracotomy. The primary outcome is the VAS scores assessed at postoperative hours 0, 3, 6, 12, and 24 for pain at rest. The secondary outcome was tramadol and morphine consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 10, 2025

Last Update Submit

January 10, 2025

Conditions

Postoperative AnalgesiaThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Visual analog scale, is one of the pain rating scales, providing a range of scores from 0-100.

    Postoperative 0., 3., 6., 12., ve 24. hour

Secondary Outcomes (1)

  • side effects

    Postoperative 24 hours

Study Arms (2)

erector spinae block group

OTHER
Procedure: nerve block

paravertebral block group

OTHER
Procedure: nerve block

Interventions

nerve blockPROCEDURE

Nerve block for providing analgesia after thoracotomy

erector spinae block groupparavertebral block group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had undergone thoracotomy, with ASA I,II,III physical status and received ESP block or paravertebral block

You may not qualify if:

  • Patients were excluded from the study if they were emergency cases, had an ASA class IV or V status, had peripheral vascular disease, were pregnant, had heart failure, were allergic to local anesthetics, or if their medical records were inaccessible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Elzem Sen, Assoc. Prof

    University of Gaziantep

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 16, 2025

Study Start

October 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 31, 2021

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)