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

Primary Purpose

Pain, Postoperative, Spine Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative Analgesia, Ultrasound guided thoracolumbar interfascial plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

thoracolumbar interfascial plane block

sham block

Arm Description

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

Bilateral ultrasound guided sham block with 2 ml saline subcutaneously

Outcomes

Primary Outcome Measures

Opioid Consumption
First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score
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
Visual analog pain score
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.
Visual analog pain score
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
Visual analog pain score
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
Visual analog pain score
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.
Visual analog pain score
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

Full Information

First Posted
March 6, 2017
Last Updated
May 16, 2017
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT03079076
Brief Title
Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery
Acronym
TLIP
Official Title
Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery: A New Approach
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Spine Disease
Keywords
Postoperative Analgesia, Ultrasound guided thoracolumbar interfascial plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thoracolumbar interfascial plane block
Arm Type
Active Comparator
Arm Description
Bilateral ultrasound guided thoracolumbar interfascial plane block with 20 ml %0,25 bupivacaine
Arm Title
sham block
Arm Type
Placebo Comparator
Arm Description
Bilateral ultrasound guided sham block with 2 ml saline subcutaneously
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
ultrasound guided thoracolumbar interfascial plane block
Intervention Description
20 ml %0,25 bupivacaine bilaterally
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
ultrasound guided sham block
Intervention Description
2 ml saline subcutaneously bilaterally
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
First 24 hours total fentanyl consumption with patient controlled analgesia
Time Frame
First 24 hours total opioid consumption
Secondary Outcome Measure Information:
Title
Visual analog pain score
Description
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
Time Frame
postoperative first hour
Title
Visual analog pain score
Description
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.
Time Frame
postoperative second hour
Title
Visual analog pain score
Description
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
Time Frame
postoperative 4th hour
Title
Visual analog pain score
Description
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
Time Frame
postoperative 8th hour
Title
Visual analog pain score
Description
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.
Time Frame
postoperative 12th hour
Title
Visual analog pain score
Description
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
Time Frame
postoperative 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26149600
Citation
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.
Results Reference
background
PubMed Identifier
28243853
Citation
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.
Results Reference
background
PubMed Identifier
27687388
Citation
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.
Results Reference
background

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Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery

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