NCT04548076

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

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

First Submitted

Initial submission to the registry

September 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

September 7, 2020

Last Update Submit

March 12, 2022

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 yea

Interventions

Block groupOTHER

Control group

Also known as: Patients received thoracolumbar interfascial plane block before operation

Eligibility Criteria

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

Vertebral surgery patients who will be operated under general anesthesia.

You may qualify if:

  • Over 18 years of age, Planned to vertebral surgery, 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

Related Publications (1)

  • Tapar H, Demir O, Genc A, Balta MG, Kolukcu V, Karaman T, Dogru S, Karaman S, Suren M. Investigation of the analgesic efficacy of ultrasound-guided thoracolumbar interfacial plane block in vertebral surgery: A prospective randomized clinical study. Saudi Med J. 2022 Oct;43(10):1136-1141. doi: 10.15537/smj.2022.43.10.20220467.

    PMID: 36261200DERIVED

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Hakan Tapar

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

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 7, 2020

First Posted

September 14, 2020

Study Start

September 7, 2020

Primary Completion

August 21, 2021

Study Completion

November 7, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)