- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Cankaya
-
Ankara, Cankaya, Turkey
- Ankara City Hospital, Bilkent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Dhanjal S, Tonder S. Quadratus Lumborum Block. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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