Modified-Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block Following Lumbar Instrumentation Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ultrasound (US)-guided peripheral nerve blocks have been used increasily 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 logissimus 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 US guidance. Therefore, modified-TLIP (mTLIP) block was defined as a new approach. It has been reported that mTLIP block may provide effective analgesia management after lumbar spine surgery.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. It has been reported that ESPB provides lumbar analgesia at T10-12, L3. The aim of this study is to compare US-guided mTLIP block and ESPB pain management after multi-level lumbar spinal instrumentation surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery

NCT04073095

Lumbar Disc Herniation

COMPLETED NA

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

NCT03854240

Lumbar Disc Herniation

COMPLETED NA

Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery

NCT03079076

Pain, Postoperative Spine Disease

COMPLETED PHASE4

An mTLIP Block for Analgesia Management After Lumbar Spinal Surgery.

NCT03967314

Lumbar Disc Herniation

COMPLETED NA

mTLIP vs. ITP Blocks in Lumbar Disc Surgery

NCT06391541

Lumbar Disc Herniation Pain, Postoperative Regional Aneshesia

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Posterior multi-level lumbar spinal instrumentation surgery is one of the most common surgeries performed for the treatment of leg and back pain. 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 spinal instrumentation 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.

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).

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided interfascial plane blocks have been used increasily 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. In this technique, local anesthetic solution is injected between the multifidus and logissimus 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 (mTLIP) block as a new approach. 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. It has been reported that this technique provides effective analgesia after lumbar spinal surgery.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016 The ESPB contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 level. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery.

The aim of this study is to evaluate US-guided mTLIP block and ESPB compared to no intervention control group for postoperative analgesia management after multi-level (two or three level) lumbar spinal instrumentation surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), motor blockade, the mobilization time, adverse effects related with opioids (allergic reaction, nausea, vomiting).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spine Instability Lumbar Spinal Stenosis Lumbar Disc Disease Lumbar Spine Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are three models for this study. The first group is erector spinae plane block group. The second one is thoracal paravertebral block group. The third one is the no intervention control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group E = ESPB group

In group E, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted cranio caudal direction and then for correction of the needle 2 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block in each side (total 40 mL).

Group Type ACTIVE_COMPARATOR