NCT03854240

Brief Summary

US-guided peripheral nerve blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. TLIP block is one of these nerve blocks performed under US guidance. In this technique, local anesthetic solution is injected between the multifidus and longissimus muscles nearly at the level of the 3rd lumbar vertebra and targets the dorsal rami of the thoracolumbar nerves. However, the visualisation of this technique may be difficult under ultrasound (US) guidance. Therefore, Ahiskalioglu et al. defined modified lateral technique of TLIP block as a new approach. The aim of this study is to compare US-guided classic and modified (lateral) techniques of TLIP block for postoperative analgesia management after lumbar laminectomy surgery .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

February 23, 2019

Last Update Submit

February 3, 2020

Conditions

Keywords

Thoracolumbar Interfascial Plane BlockPain ManagementLumbar Laminectomy Surgery

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    The primary aim is to compare perioperative and postoperative opioid consumption

    up to 3 months

Secondary Outcomes (1)

  • Visual analogue scores (VAS)

    up to 3 months

Study Arms (2)

Classic block (Group C)

ACTIVE COMPARATOR

In group C, classic technique will be performed. US probe will be placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe will be moved forward to the lateral to visualize the longissimus and multifidus muscles. Between these muscles, block needle will be inserted within in plane technique in a lateral-to-medial direction in the interfascial plane. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL)

Other: Classic block (Group C) and modified block (Group M) groups

Modified block (Group M)

ACTIVE COMPARATOR

In group M, modified technique will be performed. US probe will be placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe will be moved forward to the lateral to visualize the longissimus and iliocostal muscles. Between these muscles, block needle will be inserted within in plane technique in a medial-to-lateral direction in the interfascial plane. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL)

Other: Classic block (Group C) and modified block (Group M) groups

Interventions

Classic block (Group C) and modified block (Group M) will be performed following induction of general anesthesia, with patients in the prone position by using ultrasound device

Classic block (Group C)Modified block (Group M)

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II
  • scheduled for lumbar laminectomy surgery

You may not qualify if:

  • bleeding diathesis
  • receiving anticoagulant treatment
  • known local anesthetics and opioid allergy
  • infection of the skin at the site of the needle puncture
  • pregnancy or lactation
  • patients who do not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

  • 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
  • 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
  • Ueshima H, Ozawa T, Toyone T, Otake H. Efficacy of the Thoracolumbar Interfascial Plane Block for Lumbar Laminoplasty: A Retrospective Study. Asian Spine J. 2017 Oct;11(5):722-725. doi: 10.4184/asj.2017.11.5.722. Epub 2017 Oct 11.

    PMID: 29093781BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementAgnosia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the patient and the anesthesiologist who will evaluate postoperative pain will be blinded to the procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Classic block (Group C) and modified block (Group M) will be performed following induction of general anesthesia, with patients in the prone position
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2019

First Posted

February 26, 2019

Study Start

November 1, 2018

Primary Completion

January 30, 2020

Study Completion

January 31, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

We will not share IPD

Locations