Skip to main content
OpenTrials
Completed

NCT Number: NCT05845788

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postprocedural Analgesia Erector Spina Plan Block Opioid Consumption Quadratus Lumborum Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital, Bilkent

Ankara, Cankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Peripheral nerve block

Procedure

Ultrasound guided peripheral nerve block

Primary outcomes

  1. İntraoperative remifentanil consumption

    Time frame: At the end of the intraoperative period

    The investigators aimed to compare intraoperative remifentanil consumption of two groups

  2. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

  3. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

  4. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

  5. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

  6. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

  7. Postoperative tramadol consumption

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

    The investigators aimed to compare postoperative tramadol consumption of two groups

Secondary outcomes

  1. Postoperative nausea and vomiting

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

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

  2. Postoperative pruritus

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

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

  3. Postoperative visual analog scale

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

    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.

  4. Postoperative visual analog scale

    Time frame: We will record at postoperative 1. hour

    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.

  5. Postoperative visual analog scale

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

    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.

  6. Postoperative visual analog scale

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

    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.

  7. Postoperative visual analog scale

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

    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.

  8. Postoperative visual analog scale

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

    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.

Other outcomes

  1. Postoperative pulse rate

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

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

  2. Postoperative pulse rate

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

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

  3. Postoperative pulse rate

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

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

  4. Postoperative pulse rate

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

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

  5. Postoperative pulse rate

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

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

  6. Postoperative pulse rate

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

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

  7. Postoperative oxygen saturation

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

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

  8. Postoperative oxygen saturation

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

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

  9. Postoperative oxygen saturation

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

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

  10. Postoperative oxygen saturation

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

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

  11. Postoperative oxygen saturation

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

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

  12. Postoperative oxygen saturation

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

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

  13. Postoperative sistolic and diastolic blood pressure

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

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

  14. Postoperative sistolic and diastolic blood pressure

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

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

  15. Postoperative sistolic and diastolic blood pressure

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

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

  16. Postoperative sistolic and diastolic blood pressure

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

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

  17. Postoperative sistolic and diastolic blood pressure

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

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

  18. Postoperative sistolic and diastolic blood pressure

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

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

  19. Change from baseline systolic and diastolic blood pressure

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

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

  20. Change from baseline pulse rate

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

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

  21. Change from baseline oxygen saturation

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

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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.