NCT04544423

Brief Summary

To determine the postoperative analgesic efficiency of ultrasound-guided lumbar erector spinae plane block, patients are divided into two groups. Study group received ultrasound-guided lumbar erector spinae plane block, where control had none. Visual analog scale and opioid consumption are recorded.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 2, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 3, 2020

Last Update Submit

September 3, 2020

Conditions

Block

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    Visual analog scale

    one time in postoperative period for one year

Secondary Outcomes (1)

  • Opioid consumption

    During postoperative period for one year

Interventions

Block groupOTHER

Patients received lumbar erector spinae plane Block before operation

Also known as: Control group

Eligibility Criteria

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

Knee prosthesis patients who will be operated under general anesthesia.

You may qualify if:

  • Over 18 years of age Planned to knee prosthesis An American Society of Anesthesiologists score of 1,2 or 3

You may not qualify if:

  • Severe cardiovascular disease Psychiatric diseases Rejected to participation Those who have chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hakan Tapar

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Tapar

CONTACT

03562129500hakantapar@hotmail.com

Serkan Karaman

CONTACT

03562129500serkankaraman52@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tokat Gaziosmanpasa University

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

September 2, 2020

Primary Completion

September 2, 2021

Study Completion

September 2, 2021

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)