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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postprocedural Analgesia
Opioid Consumption
Erector Spina Plan Block
Quadratus Lumborum Block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: İntraoperative remifentanil consumption
timeFrame: At the end of the intraoperative period
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 0. hour
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 1. hour
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 2. hour
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 6. hour
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 12. hour
measure: Postoperative tramadol consumption
timeFrame: The investigators will record at postoperative 24. hour
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: The investigators will record within 24 hours postoperatively.
measure: Postoperative pruritus
timeFrame: The investigators will record within 24 hours postoperatively.
measure: Postoperative visual analog scale
timeFrame: The investigators will record at postoperative 0. hour
measure: Postoperative visual analog scale
timeFrame: We will record at postoperative 1. hour
measure: Postoperative visual analog scale
timeFrame: The investigators will record at postoperative 2. hour
measure: Postoperative visual analog scale
timeFrame: The investigators will record at postoperative 6. hour
measure: Postoperative visual analog scale
timeFrame: The investigators will record at postoperative 12. hour
measure: Postoperative visual analog scale
timeFrame: The investigators will record at postoperative 24. hour
Other outcomes:
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 0. hour
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 1. hour
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 2. hour
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 6. hour
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 12. hour
measure: Postoperative pulse rate
timeFrame: The investigators will record at postoperative 24. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 0. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 1. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 2. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 6. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 12. hour
measure: Postoperative oxygen saturation
timeFrame: The investigators will record at postoperative 24. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 0. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 1. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 2. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 6. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 12. hour
measure: Postoperative sistolic and diastolic blood pressure
timeFrame: The investigators will record at postoperative 24. hour
measure: Change from baseline systolic and diastolic blood pressure
timeFrame: The investigators will record every 10 minutes until the end of the surgery
measure: Change from baseline pulse rate
timeFrame: The investigators will record every 10 minutes until the end of the surgery
measure: Change from baseline oxygen saturation
timeFrame: The investigators will record every 10 minutes until the end of the surgery
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital, Bilkent
state: Cankaya
Study officials:
References:
citation: 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.
citation: Dhanjal ST, Tonder S. Quadratus Lumborum Block. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
citation: 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.
citation: 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.