Quadratus Lumborum Block for Lumbar Spinal Surgery

NCT ID: NCT04981301

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2022-01-01

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).

Conditions

Lumbar Disc Herniation

Study Design

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

Study Groups

Group Q = QLB group

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.

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Block

Intervention Type: DRUG

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 using 10% povidone iodine, the convex probe will be covered with a sterile sheath and a 22G, 100 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used. After visualizing the abdominal muscles with the anterior approach, the needle will be punctured in the Petit triangle and 5 ml of saline will be injected into the anterolateral 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 C = Control group

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.

Wound local anesthetic infiltration will be applied to the patients in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Quadratus Lumborum Block

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 using 10% povidone iodine, the convex probe will be covered with a sterile sheath and a 22G, 100 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used. After visualizing the abdominal muscles with the anterior approach, the needle will be punctured in the Petit triangle and 5 ml of saline will be injected into the anterolateral 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).

Intervention Type: DRUG

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

• 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

Primary researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30688787 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28154824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28235503 (View on PubMed)

Other Identifiers

Medipol Hospital 19

Identifier Type: -

Identifier Source: org_study_id