NCT04235530

Brief Summary

The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

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

April 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 13, 2020

Last Update Submit

January 17, 2020

Conditions

Postoperative Pain

Keywords

thoracoscopic surgery video assistedserratus anteriorparavertebral block

Outcome Measures

Primary Outcomes (2)

  • pain scores in rest and coughing

    Pain scores observed after surgery at 0, 1 ,2 ,6 ,12 ,24 th hours by visual analog scale. We assessed pain scores both in rest and coughing. This scale scores pain from 0 to 10. 0 means no pain and 10 means unbearable pain.

    24 hours

  • consumption of opioids

    We observed how much opioid ( how many miligrams) the patient consumed in 24 hours postoperatively with pca device.

    24 hours

Secondary Outcomes (2)

  • postoperative complications

    24 hours

  • lenght of hospital stay

    48 hours

Study Arms (1)

VAS and DVAS

To measure the pain score of patients after surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

who underwent elective video-assisted thoracoscopic surgery

You may qualify if:

  • aged between 18 and 65 years
  • ASA (American Society of Anesthesiologists) score I-II

You may not qualify if:

  • inability to communicate
  • body mass index (BMI) \> 35 kg/m2
  • infection in the area where the block was to be applied
  • allergy to the drugs used
  • mentally impaired
  • bleeding impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Education and Research Hospital

Bursa, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 22, 2020

Study Start

April 15, 2018

Primary Completion

October 15, 2018

Study Completion

February 1, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)