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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

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 14, 2017
Last Update Posted Date May 17, 2017
Actual Study Start Date  ICMJE March 15, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
Opioid Consumption [ Time Frame: First 24 hours total opioid consumption ]
First 24 hours total fentanyl consumption with patient controlled analgesia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03079076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery
Official Title  ICMJE Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery: A New Approach
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Spine Disease
Intervention  ICMJE
  • Drug: Bupivacaine
    20 ml %0,25 bupivacaine bilaterally
    Other Name: ultrasound guided thoracolumbar interfascial plane block
  • Drug: Saline
    2 ml saline subcutaneously bilaterally
    Other Name: ultrasound guided sham block
Study Arms  ICMJE
  • Active Comparator: thoracolumbar interfascial plane block
    Bilateral ultrasound guided thoracolumbar interfascial plane block with 20 ml %0,25 bupivacaine
    Intervention: Drug: Bupivacaine
  • Placebo Comparator: sham block
    Bilateral ultrasound guided sham block with 2 ml saline subcutaneously
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 17, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03079076
Other Study ID Numbers  ICMJE AUTF ANESTHESIA4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ali Ahiskalioglu, Ataturk University
Study Sponsor  ICMJE Ataturk University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ataturk University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP