NCT03079076

Brief Summary

Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015 by Hand et al. TLIP block involves injection of local anesthetics between multifidus and longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of thoracolumbar nerves. In new approach differently, the investigators made the injection between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral. The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar interfascial plane (TLIP) block in patients undergoing spinal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

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

March 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

March 6, 2017

Last Update Submit

May 16, 2017

Conditions

Pain, PostoperativeSpine Disease

Keywords

Postoperative AnalgesiaUltrasound guided thoracolumbar interfascial plane block

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    First 24 hours total opioid consumption

Secondary Outcomes (6)

  • Visual analog pain score

    postoperative first hour

  • Visual analog pain score

    postoperative second hour

  • Visual analog pain score

    postoperative 4th hour

  • Visual analog pain score

    postoperative 8th hour

  • Visual analog pain score

    postoperative 12th hour

  • +1 more secondary outcomes

Study Arms (2)

thoracolumbar interfascial plane block

ACTIVE COMPARATOR

Bilateral ultrasound guided thoracolumbar interfascial plane block with 20 ml %0,25 bupivacaine

Drug: Bupivacaine

sham block

PLACEBO COMPARATOR

Bilateral ultrasound guided sham block with 2 ml saline subcutaneously

Drug: Saline

Interventions

BupivacaineDRUG

20 ml %0,25 bupivacaine bilaterally

Also known as: ultrasound guided thoracolumbar interfascial plane block
thoracolumbar interfascial plane block
SalineDRUG

2 ml saline subcutaneously bilaterally

Also known as: ultrasound guided sham block
sham block

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing spinal surgery

You may not qualify if:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (3)

  • Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

    PMID: 26149600BACKGROUND

  • Ahiskalioglu A, Alici HA, Selvitopi K, Yayik AM. Ultrasonography-guided modified thoracolumbar interfascial plane block: a new approach. Can J Anaesth. 2017 Jul;64(7):775-776. doi: 10.1007/s12630-017-0851-y. Epub 2017 Feb 27. No abstract available.

    PMID: 28243853BACKGROUND

  • Ueshima H, Oku K, Otake H. Ultrasound-guided thoracolumbar interfascial plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2016 Nov;34:259-60. doi: 10.1016/j.jclinane.2016.04.060. Epub 2016 May 13. No abstract available.

    PMID: 27687388BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeSpinal Diseases

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 14, 2017

Study Start

March 15, 2017

Primary Completion

May 16, 2017

Study Completion

May 17, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

TU(1)