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Clinical Trials/NCT03854240
NCT03854240
Completed
Not Applicable

Comparison of Ultrasound-Guided Classic And Lateral Approach Thoracolumbar Interfascial Plane Block For Pain Management Following Lumbar Laminectomy Surgery

Medipol University1 site in 1 country60 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Disc Herniation
Sponsor
Medipol University
Enrollment
60
Locations
1
Primary Endpoint
opioid consumption
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

US-guided peripheral nerve blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. TLIP block is one of these nerve blocks performed under US guidance. In this technique, local anesthetic solution is injected between the multifidus and longissimus muscles nearly at the level of the 3rd lumbar vertebra and targets the dorsal rami of the thoracolumbar nerves. However, the visualisation of this technique may be difficult under ultrasound (US) guidance. Therefore, Ahiskalioglu et al. defined modified lateral technique of TLIP block as a new approach. The aim of this study is to compare US-guided classic and modified (lateral) techniques of TLIP block for postoperative analgesia management after lumbar laminectomy surgery .

Detailed Description

Spine surgery in thoracolumbar region is one of the most common surgeries performed for the treatment of leg and back pain 1. Pain management is especially important for these patients since chronic pain often occurs after surgery. Severe pain may occur at postoperative period in patients following lumbar disc herniation (LDH) operation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced 1,2. Regional anesthesia techniques may be preferred for postoperative analgesia management.Thoracolumbar interfascial plane (TLIP) block is a novel ultrasound guided regional analgesia technique. Several techniques such as intravenous-intramuscular injections, and patient-controlled analgesia devices are usually performed for postoperative pain management. However, these methods may be ineffective in the pain treatment due to they are generally performed after pain has occurred. The analgesic agent may not reach a treatment concentration in the blood due to administrating doses intermittently 2.Opioids are one of the most preferred drugs among the analgesic agents. Parenteral opioids are generally performed for patients after surgery. However opioids have undesirable adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events) 3. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided peripheral nerve blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. TLIP block is one of these nerve blocks performed under US guidance and defined by Hand et al. in 2015 2. In a retrospective study, it has been reported that this technique can provide effective analgesia after lumbar laminoplasty surgery by Ueshima et al 4. In this technique, local anesthetic solution is injected between the multifidus and longissimus muscles nearly at the level of the 3rd lumbar vertebra and targets the dorsal rami of the thoracolumbar nerves. However, the visualisation of this technique may be difficult under ultrasound (US) guidance. Therefore, Ahiskalioglu et al. defined modified lateral technique of TLIP block as a new approach 5. Ahiskalioglu et al. have reported that this approach has some advantages. Firstly, sonographic visualisation is more easily than the classical technique. Secondly, insertion of the needle from medial to lateral direction reduces the risk of possible neuraxial injection 5. The aim of this study is to compare US-guided classic and modified (lateral) techniques of TLIP block for postoperative analgesia management after lumbar laminectomy surgery . The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to blocks.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
January 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Principal Investigator

Medipol University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • scheduled for lumbar laminectomy surgery

Exclusion Criteria

  • bleeding diathesis
  • receiving anticoagulant treatment
  • known local anesthetics and opioid allergy
  • infection of the skin at the site of the needle puncture
  • pregnancy or lactation
  • patients who do not accept the procedure

Outcomes

Primary Outcomes

opioid consumption

Time Frame: up to 3 months

The primary aim is to compare perioperative and postoperative opioid consumption

Secondary Outcomes

  • Visual analogue scores (VAS)(up to 3 months)

Study Sites (1)

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