QLB vs mTLIP for Lumbar Spinal Surgery

NCT05217121 | Completed

• 1 other identifier: Medipol Hospital 25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided quadratus lumborum block (QLB) is a fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves. In TLIP block, 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. 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 aim of this study is to compare US-guided mTLIP block and QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery.

Conditions

Lumbar Disc Herniation

Keywords

Lumbar Disc Herniation; Postoperative pain management; Quadratus Lumborum Block; mTLIP block

Outcome Measures

Primary Outcomes (1)

• Global recovery scoring system (patient satisfaction scale)

  This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions).

  Change from baseline score at postoperative 24 hour

Secondary Outcomes (2)

• The use of rescue analgesia (number of participants and rate of tramodol using)

  Postoperative 24 hours period

• Postoperative pain scores (NRS)

  Postoperative 24 hours period

Study Arms (2)

Group Q = QLB group

ACTIVE COMPARATOR

Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Tramodol will be performed for rescue analgesia.

Other: Quadratus Lumborum Block

Group M = mTLIP block group

ACTIVE COMPARATOR

Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Tramodol will be performed for rescue analgesia.

Other: Modified-thoracolumbar interfascial plane block

Interventions

Quadratus Lumborum Block OTHER

The block procedure will be applied after the surgery and before extubation with patients in the prone position by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions, the probe will be covered with a sterile sheath and a 22G, 80 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used. After visualizing the abdominal muscles, the needle will be punctured and 5 ml of saline will be injected into the postero-lateral border of the quadratus lumborum muscle. After the block location is confirmed, 15 ml of 0.25% bupivacaine will be injected. The same process will be applied to the opposite side (30 ml totally).

Group Q = QLB group

Modified-thoracolumbar interfascial plane block OTHER

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 15 mL will be injected in each side (30 ml totally).

Group M = mTLIP block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for lumbar disc herniation-laminectomy surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (2)

• Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

  PMID: 30688787 BACKGROUND

• Ahiskalioglu A, Yayik AM, Alici HA. Ultrasound-guided lateral thoracolumbar interfascial plane (TLIP) block: Description of new modified technique. J Clin Anesth. 2017 Aug;40:62. doi: 10.1016/j.jclinane.2017.04.015. No abstract available.

  PMID: 28625449 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant were blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for lumbar disc herniation surgery will be included in the study. Patients will be randomly divided into two groups (Group Q = QLB group, Group M = mTLIP group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 1, 2022
• Study Start: January 19, 2022
• Primary Completion: June 25, 2022
• Study Completion: June 29, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)