Thoracolumbar Interfascial Plane Block in Vertebral Surgery | NCT04548076

Studies
Thoracolumbar Interfascial Plane Block in Vertebral Surgery

NCT04548076

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Mar 15, 2022Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Block

Interventions

Block group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2020Actual

Primary Completion Date

Aug 21, 2021Actual

Completion Date

Nov 7, 2021Actual

First Submitted Date

Sep 7, 2020

First Submission Date that Met QC Criteria

Sep 7, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2022

Last Update Posted Date

Mar 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hakan Tapar, Tokat Gaziosmanpasa University, Tokat Gaziosmanpasa UniversityPrincipal Investigator

Lead Sponsor

Tokat Gaziosmanpasa UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Thoracolumbar interfascial plane block has successfully been demonstrated to provide an efficient analgesia in patients. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of thoracolumbar interfascial plane block in patients with vertebral surgery. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS>4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS>4 the same dose will be repeated. A patient satisfaction questionnaire (Qr40)will be filled by patients at the postoperative 24th hour.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Block group	Other	Control group		Patients received thoracolumbar interfascial plane block before operation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale	Visual analog scale	one time in postoperative period for one year

Secondary Outcomes

Measure	Description	Time Frame
Opioid consumption	Opioid consumption	During postoperative period for one yea

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years of age, Planned to vertebral surgery, An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Vertebral surgery patients who will be operated under general anesthesia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hakan Tapar	Gaziosmanpasa University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University		Tokat Province		60200	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36261200	Derived	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.

ID	Term
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries