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

Sponsor
Medipol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04189341
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
35.6
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Erector spinae plane block (Group E)
  • Drug: Modified-thoracolumbar interfascial plane block
 N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.
Primary Purpose:
Treatment
Official Title:
Ultrasound-Guided Modified-Thoracolumbar Interfascial Plane Block and Lumbar Erector Spinae Plane Block for Pain Management Following Lumbar Spinal Instrumentation Surgery
Actual Study Start Date :
Jan 10, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

Drug: Erector spinae plane block (Group E)
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Active Comparator: Group T = mTLIP group

In group T, mTLIP block 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).

Drug: Modified-thoracolumbar interfascial plane block
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
No Intervention: Group C = Control group

Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [Change from Baseline Postoperative Visual Analogue Score at 48 hours]

    The primary aim is to compare perioperative and postoperative opioid consumption

Secondary Outcome Measures

  1. Visual analogue scores (VAS) [Postoperative 1, 2, 4, 8, 16, 24, and 48 hours]

    Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II

  • scheduled for VATS under general anesthesia

Exclusion Criteria:

  • history of 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Bagcilar Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahadir Ciftci, Principal Investigator, Medipol University
ClinicalTrials.gov Identifier:
NCT04189341
Other Study ID Numbers:
  • Medipol Hospital 6
First Posted:
Dec 6, 2019
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bahadir Ciftci, Principal Investigator, Medipol University
Modified-thoracolumbar interfascial plane block
Erector spina plane block
Postoperative analgesia management
Lumbar spinal instrumentation surgery
Additional relevant MeSH terms:
Spinal Stenosis

Study Results

No Results Posted as of Feb 11, 2022