NCT04886375

Brief Summary

This study aims to compare the effects of the erector spinae plan block (ESP) and modified pectoral nerve block (PECS II) on postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery (VATS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 10, 2021

Last Update Submit

May 10, 2021

Conditions

Postoperative AnalgesiaVideo-assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24-hours total morphine consumption

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

    24 hours postoperatively

Secondary Outcomes (1)

  • NRS scores of patients

    24 hours postoperatively

Study Arms (2)

esp group

ACTIVE COMPARATOR

The investigators performed erector spina plane block to that patient group for postoperative analgesia

Procedure: erector spina plane block

pecs group

ACTIVE COMPARATOR

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

Procedure: modified pectoral nerve block

Interventions

erector spina plane blockPROCEDURE

The investigators performed erector spina plane block to that patient group for postoperative analgesia

esp group
modified pectoral nerve blockPROCEDURE

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

pecs 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:

  • 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
  • Patients with ASA IV-V

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 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
MD

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

April 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations

TU(1)