Comparison of Ultrasound-Guided Classic And Lateral Approach Thoracolumbar Interfascial Plane Block

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854240
• Other study ID #: Medipol University
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Other:
• Classic block (Group C) and modified block (Group M) groups
Classic block (Group C) and modified block (Group M) will be performed following induction of general anesthesia, with patients in the prone position by using ultrasound device

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View Citation

Ueshima H, Ozawa T, Toyone T, Otake H. Efficacy of the Thoracolumbar Interfascial Plane Block for Lumbar Laminoplasty: A Retrospective Study. Asian Spine J. 2017 Oct;11(5):722-725. doi: 10.4184/asj.2017.11.5.722. Epub 2017 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption	The primary aim is to compare perioperative and postoperative opioid consumption	up to 3 months
Secondary	Visual analogue scores (VAS)	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt).	up to 3 months