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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079076
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Ahiskalioglu, Ataturk University

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Spine Disease Drug: Bupivacaine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery: A New Approach
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : May 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: ultrasound guided sham block




Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: First 24 hours total opioid consumption ]
    First 24 hours total fentanyl consumption with patient controlled analgesia


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079076


Locations
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Turkey
Ataturk University
Erzurum, Turkey
Sponsors and Collaborators
Ataturk University

Publications:
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Responsible Party: Ali Ahiskalioglu, MD, Ataturk University
ClinicalTrials.gov Identifier: NCT03079076     History of Changes
Other Study ID Numbers: AUTF ANESTHESIA4
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Ahiskalioglu, Ataturk University:
Postoperative Analgesia
Ultrasound guided thoracolumbar interfascial plane block
Additional relevant MeSH terms:
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Spinal Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents