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

Quadratus Lumborum Block Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05845788
• Other study ID #: E1-23-.3166
• Status: Completed
• Start date: April 15, 2023
• Est. completion date: August 2, 2023

Study information

• Verified date: October 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption
• Quadratus Lumborum Block

Intervention

Procedure:
• Peripheral nerve block
Ultrasound guided peripheral nerve block

Locations

Country	Name	City	State
Turkey	Ankara City Hospital, Bilkent	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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/ — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 0. hour
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 1. hour
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 2. hour
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 6. hour
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 12. hour
Other	Postoperative pulse rate	The investigators aimed to compare patient's pulse rates of two groups.	The investigators will record at postoperative 24. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 0. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 1. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 2. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 6. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 12. hour
Other	Postoperative oxygen saturation	The investigators aimed to compare patient's intraoperative oxygen saturations of two groups	The investigators will record at postoperative 24. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups	The investigators will record at postoperative 0. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups	The investigators will record at postoperative 1. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups	The investigators will record at postoperative 2. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups	The investigators will record at postoperative 6. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups	The investigators will record at postoperative 12. hour
Other	Postoperative sistolic and diastolic blood pressure	The investigators aimed to compare patient's blood pressures of two groups.	The investigators will record at postoperative 24. hour
Other	Change from baseline systolic and diastolic blood pressure	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
Other	Change from baseline pulse rate	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
Other	Change from baseline oxygen saturation	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
Primary	Intraoperative remifentanil consumption	The investigators aimed to compare intraoperative remifentanil consumption of two groups	At the end of the intraoperative period
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 0. hour
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 1. hour
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 2. hour
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 6. hour
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 12. hour
Primary	Postoperative tramadol consumption	The investigators aimed to compare postoperative tramadol consumption of two groups	The investigators will record at postoperative 24. hour
Secondary	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.	The investigators will record within 24 hours postoperatively.
Secondary	Postoperative pruritus	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.
Secondary	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.	The investigators will record at postoperative 0. hour
Secondary	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.	We will record at postoperative 1. hour
Secondary	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.	The investigators will record at postoperative 2. hour
Secondary	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.	The investigators will record at postoperative 6. hour
Secondary	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.	The investigators will record at postoperative 12. hour
Secondary	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.	The investigators will record at postoperative 24. hour