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Quadratus Lumborum Block for Lumbar Spinal Surgery

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus Lumborum Block
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar Disc Herniation, Postoperative pain management, Quadratus Lumborum Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group Q = QLB group

Group C = Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain scores
Change from Baseline Pain Scores at Postoperative 24 hours.

Secondary Outcome Measures

The use of rescue analgesia
Tramodol using

Full Information

First Posted
July 17, 2021
Last Updated
February 10, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04981301
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar Disc Herniation, Postoperative pain management, Quadratus Lumborum Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant were blinded to the study
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Q = QLB group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C = Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Change from Baseline Pain Scores at Postoperative 24 hours.
Time Frame
Postoperative 24 hours period
Secondary Outcome Measure Information:
Title
The use of rescue analgesia
Description
Tramodol using
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
30688787
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.
Results Reference
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PubMed Identifier
28154824
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.
Results Reference
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PubMed Identifier
28235503
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.
Results Reference
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Quadratus Lumborum Block for Lumbar Spinal Surgery

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