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

October 31, 2023 updated by: Nihal Gökbulut Özaslan, Ankara City Hospital Bilkent
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cankaya
      • Ankara, Cankaya, Turkey
        • Ankara City Hospital, Bilkent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Erector Spina Plan Block Group (Group E)
Patients who underwent erector spina plane block before initiation of surgery after induction of anesthesia
Ultrasound guided 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
Ultrasound guided peripheral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
İntraoperative remifentanil consumption
Time Frame: At the end of the intraoperative period
The investigators aimed to compare intraoperative remifentanil consumption of two groups
At the end of the intraoperative period
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 0. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 0. hour
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 1. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 1. hour
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 2. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 2. hour
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 6. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 6. hour
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 12. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 12. hour
Postoperative tramadol consumption
Time Frame: The investigators will record at postoperative 24. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
The investigators will record at postoperative 24. hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The investigators will record at postoperative 0. hour
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.
We will record at postoperative 1. hour
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.
The investigators will record at postoperative 2. hour
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.
The investigators will record at postoperative 6. hour
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.
The investigators will record at postoperative 12. hour
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.
The investigators will record at postoperative 24. hour
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.
The investigators will record within 24 hours postoperatively.
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.
The investigators will record within 24 hours postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The investigators will record every 10 minutes until the end of the surgery
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
The investigators will record every 10 minutes until the end of the surgery
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
The investigators will record every 10 minutes until the end of the surgery
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
The investigators will record at postoperative 0. hour
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
The investigators will record at postoperative 1. hour
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
The investigators will record at postoperative 2. hour
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
The investigators will record at postoperative 6. hour
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
The investigators will record at postoperative 12. hour
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.
The investigators will record at postoperative 24. hour
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.
The investigators will record at postoperative 0. hour
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.
The investigators will record at postoperative 1. hour
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.
The investigators will record at postoperative 2. hour
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.
The investigators will record at postoperative 6. hour
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.
The investigators will record at postoperative 12. hour
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.
The investigators will record at postoperative 24. hour
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
The investigators will record at postoperative 0. hour
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
The investigators will record at postoperative 1. hour
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
The investigators will record at postoperative 2. hour
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
The investigators will record at postoperative 6. hour
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
The investigators will record at postoperative 12. hour
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
The investigators will record at postoperative 24. hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Actual)

August 2, 2023

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • E1-23-.3166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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