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CompletedNCT05845788Updated Nov 2, 2023

Comparison of the Intraoperative and Postoperative Effects of Ultrasound-guided Erector Spina Plane Block and Posterior Quadratus Lumborum Block in Patients Undergoing Lumbar Stabilization Surgery

An observational study in Postprocedural Analgesia, Opioid Consumption and Erector Spina Plan Block, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
62
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The investigators aimed to compare the effects of ultrasound guided erector spina plan block and posterior quadratus lumborum block on intraoperative and postoperative opioid consumption in patients who will undergo short segment lumbar stabilization surgery.

Read the detailed description

All participants will be monitored with ECG, SpO2, non-invasive blood pressure. In induction, 1mg/kg 2% lidocaine, 2-3mg/kg propofol, 1mcg/kg fentanyl, 2mg midazolam, 0.6 mg/kg rocuronium will be used. Anesthesia depth will be monitored with BIS (bispectral index), and anesthesia will be maintained with 50% oxygen-air mixture and sevoflurane. After patient intubation, invasive artery cannulation will be performed on the non-dominant hand, and the patients will be placed in a prone position. 20 cc bupivacaine of 0.25% will be administered to both regions bilaterally, by following the rules of asepsis, with a 10 cm pajunk needle accompanied by USG, the needle site will be confirmed with 3 mm saline.

BIS will be kept in the range of 40-50 throughout the case, and invasive arterial monitoring will be performed. 1 g paracetamol, 1 mg/kg tramadol and 4 mg ondansetron will be administered to the patients 30 minutes before the end of the surgery.

After appropriate extubation and wakefulness, patients will be transferred to the postoperative anesthesia care unit (PACU), where they will be followed for 24 hours.

An intravenous (IV) patient-controlled analgesia device (PCA) containing 100ml of tramadol at a concentration of 4mg/cc will be inserted. No infusion will be given, and the bolus dose will be set to 20mg, with a lock time of 20 minutes. In the postoperative period, 50 mg of dexketoprofen will be administered every 8 hours.

VAS values, vital signs, and possible opioid side effects of the patients at 0, 1, 2, 6, 12 and 24 hours will be recorded. After completing 24 hours, the patient will be separated from the IV PCA device and transferred to the service.

02

Conditions studied

  • Postprocedural Analgesia
  • Opioid Consumption
  • Erector Spina Plan Block
  • Quadratus Lumborum Block
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 439 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who will undergo lumbar stabilization operation under general anesthesia in Ankara Bilkent City Hospital Operating Room, between the ages of 18-65, both genders, and in the ASA I-III risk group will be included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who will undergo lumbar stabilization operation
  • Between the ages of 18-65
  • Both genders
  • ASA I-III risk group

Exclusion criteria

Exclusion Criteria:

  • Patients who did not accept the study
  • Patients younger than 18 years old
  • Patients older than 65 years
  • Patients with an ASA score greater than III
  • Patients with an active infection in the area to be blocked
  • Patients with a long bleeding time
  • Those who are pregnant
  • Patients with kidney failure
  • Patients with liver failure
  • Patients with BMI\<18 and BMI>30
  • Those who are allergic to local anesthetics
  • Patients who have had previous lumbar surgery
  • Uncooperative or mentally retarded patients
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • Erector Spina Plan Block Group (Group E)

    Patients who underwent erector spina plane block before initiation of surgery after induction of anesthesia

    Procedure: Peripheral nerve block

  • Posterior Quadratus Lumborum Block Group ( Group Q)

    Patients who underwent posterior quadratus lumborum block block before initiation of surgery after induction of anesthesia

    Procedure: Peripheral nerve block

Interventions

  • ProcedurePeripheral nerve block

    Ultrasound guided peripheral nerve block

06

What researchers measure

Primary outcomes

  1. İntraoperative remifentanil consumption

    The investigators aimed to compare intraoperative remifentanil consumption of two groups

    Time frame: At the end of the intraoperative period

  2. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 0. hour

  3. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 1. hour

  4. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 2. hour

  5. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 6. hour

  6. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 12. hour

  7. Postoperative tramadol consumption

    The investigators aimed to compare postoperative tramadol consumption of two groups

    Time frame: The investigators will record at postoperative 24. hour

Secondary outcomes

  1. Postoperative nausea and vomiting

    Whether there is postoperative nausea and vomiting will be questioned by the investigators. Yes or no will be marked in the table.

    Time frame: The investigators will record within 24 hours postoperatively.

  2. Postoperative pruritus

    Whether there is postoperative pruritus will be questioned by the investigators. Yes or no will be marked in the table.

    Time frame: The investigators will record within 24 hours postoperatively.

  3. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: The investigators will record at postoperative 0. hour

  4. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: We will record at postoperative 1. hour

  5. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: The investigators will record at postoperative 2. hour

  6. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: The investigators will record at postoperative 6. hour

  7. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: The investigators will record at postoperative 12. hour

  8. Postoperative visual analog scale

    The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.

    Time frame: The investigators will record at postoperative 24. hour

Other outcomes

  1. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 0. hour

  2. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 1. hour

  3. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 2. hour

  4. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 6. hour

  5. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 12. hour

  6. Postoperative pulse rate

    The investigators aimed to compare patient's pulse rates of two groups.

    Time frame: The investigators will record at postoperative 24. hour

  7. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 0. hour

  8. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 1. hour

  9. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 2. hour

  10. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 6. hour

  11. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 12. hour

  12. Postoperative oxygen saturation

    The investigators aimed to compare patient's intraoperative oxygen saturations of two groups

    Time frame: The investigators will record at postoperative 24. hour

  13. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups

    Time frame: The investigators will record at postoperative 0. hour

  14. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups

    Time frame: The investigators will record at postoperative 1. hour

  15. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups

    Time frame: The investigators will record at postoperative 2. hour

  16. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups

    Time frame: The investigators will record at postoperative 6. hour

  17. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups

    Time frame: The investigators will record at postoperative 12. hour

  18. Postoperative sistolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures of two groups.

    Time frame: The investigators will record at postoperative 24. hour

  19. Change from baseline systolic and diastolic blood pressure

    The investigators aimed to compare patient's blood pressures change of two groups

    Time frame: The investigators will record every 10 minutes until the end of the surgery

  20. Change from baseline pulse rate

    The investigators aimed to compare patient's intraoperative pulse rates change of two groups

    Time frame: The investigators will record every 10 minutes until the end of the surgery

  21. Change from baseline oxygen saturation

    The investigators aimed to compare patient's baseline oxygen saturation change of two groups

    Time frame: The investigators will record every 10 minutes until the end of the surgery

07

Study locations

1 site
  • Ankara City Hospital, Bilkent
    Ankara, Cankaya, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 32669870 ↗
  • Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/ PubMed 30725897 ↗
  • 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. PubMed 30688787 ↗
  • Kang R, Lee S, Kim GS, Jeong JS, Gwak MS, Kim JM, Choi GS, Cho YJ, Ko JS. Comparison of Analgesic Efficacy of Erector Spinae Plane Block and Posterior Quadratus Lumborum Block in Laparoscopic Liver Resection: A Randomized Controlled Trial. J Pain Res. 2021 Dec 11;14:3791-3800. doi: 10.2147/JPR.S343366. eCollection 2021. PubMed 34924770 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05845788
Responsible party
Nihal Gökbulut Özaslan (Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
May 6, 2023
Start date
Apr 15, 2023
Primary completion
Aug 2, 2023
Completion
Aug 2, 2023
Last update
Nov 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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