Clinical trial NCT04981301: Quadratus Lumborum Block for Lumbar Spinal Surgery
Official title: The Efficacy of Ultrasound-Guided Quadratus Lumborum Block for Pain Management Following Lumbar Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Lumbar Disc Herniation
Postoperative pain management
Quadratus Lumborum Block
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ninety 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 C = Control group) including 30 patients each, before entering the operating room.
Primary purpose: TREATMENT

Brief summary: Spine surgery in thoracolumbar region 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 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.

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.

The aim of this study is to evaluate the efficacy of US-guided QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery. The primary aim is to evaluate postoperative pain scores (VAS), the secondary aim is to evaluate use of rescue analgesia and adverse effects (allergic reaction, nausea, vomiting).

Detailed description: Spine surgery in thoracolumbar region 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 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.

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. 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.

The aim of this study is to evaluate the efficacy of US-guided QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery. The primary aim is to evaluate postoperative pain scores (VAS), the secondary aim is to evaluate use of rescue analgesia and adverse effects (allergic reaction, nausea, vomiting).

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Postoperative pain scores
timeFrame: Postoperative 24 hours period
Secondary outcomes:
measure: The use of rescue analgesia
timeFrame: Postoperative 24 hours period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bagcilar
Study officials:
References:
citation: 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.
citation: Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
citation: Ueshima H, Otake H. RETRACTED: Clinical experience of anterior quadratus lumborum block after lumber surgery. J Clin Anesth. 2017 Feb;37:131. doi: 10.1016/j.jclinane.2016.12.014. Epub 2017 Jan 9. No abstract available.