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Completed

NCT Number: NCT03079076

Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery

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.

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Key information

Conditions

Pain, Postoperative Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Diseases Spine Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ataturk University

Erzurum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

20 ml %0,25 bupivacaine bilaterally

Other names: ultrasound guided thoracolumbar interfascial plane block

Saline

Drug

2 ml saline subcutaneously bilaterally

Other names: ultrasound guided sham block

Primary outcomes

  1. Opioid Consumption

    Time frame: First 24 hours total opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: TLIP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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