Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery (TLIP)

May 16, 2017 updated by: Ali Ahiskalioglu, Ataturk University

Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery: A New Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: thoracolumbar interfascial plane block
Bilateral ultrasound guided thoracolumbar interfascial plane block with 20 ml %0,25 bupivacaine
Drug: Bupivacaine
20 ml %0,25 bupivacaine bilaterally
Other Names:
  • ultrasound guided thoracolumbar interfascial plane block
Placebo Comparator: sham block
Bilateral ultrasound guided sham block with 2 ml saline subcutaneously
Drug: Saline
2 ml saline subcutaneously bilaterally
Other Names:
  • ultrasound guided sham block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: First 24 hours total opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
First 24 hours total opioid consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: postoperative second hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
postoperative second hour
Visual analog pain score
Time Frame: postoperative 4th hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively
postoperative 4th hour
Visual analog pain score
Time Frame: postoperative 8th hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively
postoperative 8th hour
Visual analog pain score
Time Frame: postoperative 12th hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
postoperative 12th hour
Visual analog pain score
Time Frame: postoperative first hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively
postoperative first hour
Visual analog pain score
Time Frame: postoperative 24th hour
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively
postoperative 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

May 16, 2017

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTF ANESTHESIA4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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