NCT04855994

Brief Summary

This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

June 28, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

April 9, 2021

Last Update Submit

July 4, 2021

Conditions

Thoracic Paravertebral BlockVideo-assisted Thoracoscopic SurgeryPostoperative Analgesia

Keywords

Thoracic paravertebral block,pectoralis block,Video-assisted thoracoscopic surgery,Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24-hours total morphine consumption of patients

    This will be measured only one time by pca device at the 24th hour after surgery.

    24 hours postoperatively

Secondary Outcomes (1)

  • Visual Analog Scale values of patients

    24 hours postoperatively

Study Arms (2)

paravertebral group

ACTIVE COMPARATOR

The investigators performed Paravertebral block to that patient group for postoperative analgesia

Procedure: paravertebral block

pectoral group

ACTIVE COMPARATOR

The investigators performed pectoral block to that patient group for postoperative analgesia

Procedure: pectoral block

Interventions

paravertebral blockPROCEDURE

The investigators performed Paravertebral block to that patient group for postoperative analgesia

paravertebral group
pectoral blockPROCEDURE

The investigators performed pectoral block to that patient group for postoperative analgesia

pectoral group

Eligibility Criteria

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

You may qualify if:

  • Ages of 18-65
  • Patients who will undergo VATS
  • ASA I-II-III patients

You may not qualify if:

  • Patients with ASA IV
  • Clinically diagnosis of spinal or chest wall deformity or pathology
  • Clinically known local anesthetic allergy
  • Morbid obesity (body mass index\>40 kg m2)
  • Clinically diagnosis of opioid, alcohol and substance dependence
  • Clinically diagnosis of psychiatric disease
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Study Officials

  • Gokhan Sertcakacilar, MD

    Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 22, 2021

Study Start

June 28, 2017

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

July 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)