NCT06477198

Brief Summary

Ultrasound-guided quadratus lumborum block (QLB) is a fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle to anesthetize the thoracolumbar nerves. 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. This study aims to compare US-guided ESPB and posterior QLB for postoperative analgesia management after lumbar disc herniation-laminectomy surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 6, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

June 13, 2024

Last Update Submit

August 5, 2025

Conditions

Keywords

Lumbar Disc HerniationPostoperative pain managementErector spinae plane blockQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores (NRS-Numerical Rating Scala)

    Difference in the NRS scores at postoperative 2 hours between the groups

    Postoperative 2 hours period

Secondary Outcomes (4)

  • The use of rescue analgesia (number of participants) (frequency of rescue analgesia)

    Postoperative 24 hours period

  • The use of rescue analgesia (rate of tramadol using) (total consumption)

    Postoperative 24 hours period

  • Postoperative pain scores (NRS-Numerical Rating Scala)

    Changes from baseline pain scores at postoperative 1, 4, 8, 16 and 24 hours

  • The incidence of adverse events

    Postoperative 24 hours period

Study Arms (2)

Group QLB = QLB group

ACTIVE COMPARATOR

Posterior QLB will be performed

Other: QLBOther: Postoperative analgesia management

Group ESPB = ESPB Group

ACTIVE COMPARATOR

Lumbar ESPB will be performed

Other: ESPBOther: Postoperative analgesia management

Interventions

QLBOTHER

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 convex 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 quadratus lumborum muscle, the needle will be punctured and 5 ml of saline will be injected into the posterior border of the quadratus lumborum muscle between QLM and latissimus dorsi muscle.. After the block location is confirmed, 30 ml of 0.25% bupivacaine will be injected. The same process will be applied to the opposite side (60 ml totally).

Group QLB = QLB group
ESPBOTHER

ESP block will be performed. Convex probe will be placed longitudinally 4 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 injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for the block in each side (total 60 mL).

Group ESPB = ESPB 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. Tramodol will be performed for rescue analgesia.

Group ESPB = ESPB GroupGroup QLB = QLB group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Change in surgical technique in the intraoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (5)

  • Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.

    PMID: 35030493BACKGROUND
  • Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.

    PMID: 32669870BACKGROUND
  • Tulgar S, Aydin ME, Ahiskalioglu A, De Cassai A, Gurkan Y. Anesthetic Techniques: Focus on Lumbar Erector Spinae Plane Block. Local Reg Anesth. 2020 Sep 25;13:121-133. doi: 10.2147/LRA.S233274. eCollection 2020.

    PMID: 33061562BACKGROUND
  • Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Ultan Ozgen G, Akdeniz S, Bayraktar B, Tulgar S, Yigit Y. Posterior Quadratus Lumborum Block or Thoracolumbar Interfascial Plane Block and Postoperative Analgesia after Spinal Surgery: A Randomized Controlled Trial. J Clin Med. 2023 Nov 21;12(23):7217. doi: 10.3390/jcm12237217.

    PMID: 38068268BACKGROUND
  • Alver S, Ciftci B, Celik EC, Sargolzaeimoghaddam M, Cetinkal A, Erdogan C, Ahiskalioglu A. Postoperative recovery scores and pain management: a comparison of modified thoracolumbar interfascial plane block and quadratus lumborum block for lumbar disc herniation. Eur Spine J. 2024 Jan;33(1):118-125. doi: 10.1007/s00586-023-07812-3. Epub 2023 Jun 14.

    PMID: 37314577BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological 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
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 QLB = QLB group, Group ESPB = ESPB group) including 30 patients each, before entering the operating room.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 27, 2024

Study Start

August 6, 2024

Primary Completion

February 20, 2025

Study Completion

February 22, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared

Locations