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

NCT ID: NCT03854240

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-01-31

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.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Classic block (Group C)

In group C, classic technique will be performed. US probe will be placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe will be moved forward to the lateral to visualize the longissimus and multifidus muscles. Between these muscles, block needle will be inserted within in plane technique in a lateral-to-medial direction in the interfascial plane. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL)

Group Type: ACTIVE_COMPARATOR

Classic block (Group C) and modified block (Group M) groups

Intervention Type: OTHER

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

Modified block (Group M)

In group M, modified technique will be performed. US probe will be placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe will be moved forward to the lateral to visualize the longissimus and iliocostal muscles. Between these muscles, block needle will be inserted within in plane technique in a medial-to-lateral direction in the interfascial plane. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL)

Group Type: ACTIVE_COMPARATOR

Classic block (Group C) and modified block (Group M) groups

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Bahadir Ciftci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 28243853 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26149600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29093781 (View on PubMed)

Other Identifiers

Medipol University

Identifier Type: -

Identifier Source: org_study_id