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NCT Number: NCT05822492

Anterior Quadratus Lumborum Block Versus Erector Spina Plane Block in Percutaneous Nephrolithotomy Surgery

In this study, it was aimed to evaluate the effects of anterior quadratus lumborum block (QLB3) and Erector Spina Plane Block (ESPB) on postoperative acute pain scores and opioid consumption in the first 24 hours in Percutaneous Nephrolithotomy Surgery

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Key information

Conditions

Anesthesia Agnosia Analgesia Erector Spina Plane Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Controlled Analgesia Perceptual Disorders Quadratus Lumborum Block Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz mayıs Universty

Samsun, 55060, Turkey (Türkiye)

About this study

Percutaneous nephrolithotomy (PCNL) is commonly used to treat large kidney stones. Patients usually complain of severe pain and discomfort postoperatively. Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects.

Regional anesthesia is part of multimodal analgesia in treating postoperative pain. Facial plane blocks are among these procedures. Erector spina plane block (ESPB) is a peri-paravertebral regional anesthesia technique applied for the first time to treat thoracic neuropathic pain. In the literature, the effectiveness of upper abdomen and renal operations in pain management has been demonstrated. Quadratus lumborum block (QLB) was first described as an alternative to the transversus abdominis plane block. This block can be performed with three methods under ultrasound guidance. An anterior QLB (QLB3) block was used in this study. In this block, the local anesthetic drug is applied between the quadratus lumborum muscle and the psoas muscle fascia and spreads along the thoracolumbar fascia. This block provides anesthesia and analgesia in the T7-L1 dermatome area. QLB3 block has been applied in pyeloplasty, cholecystectomy, lower abdominal surgeries, cesarean sections, radical nephrectomy, and hip joint surgeries and provided adequate postoperative analgesia.

This study aimed to evaluate the effects of QLB3 block and ESPB block on pain scores and opioid consumption in patients undergoing PCNL.

Patients will be divided into three groups.

Group QLB3:

Patients who applied the OLB3 block and IV morphine-patient-controlled analgesia (PCA) before PCNL surgery were included in this group.

Group ESPB:

Patients who applied ESPB block and IV morphine-PCA before PCNL surgery were included in this group.

Group Control In this group, patients only applied general anesthesia and IV morphine-PCA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years
  • American Society of Anesthesiology score I-III patients scheduled for unilateral PCNL in elective conditions
  • Patients with BMI <35 kg/m2

Exclusion criteria

  • Pregnancy
  • Conditions where regional anesthesia is contraindicated (coagulopathy, international normalized ratio abnormality, thrombocytopenia, infection at the injection site)
  • History of hypersensitivity or allergy to local anesthetics
  • Patients with psychiatric disorders
  • Patients with musculoskeletal deformities
  • Patients with alcohol-drug dependence
  • Patients with cognitive dysfunction (patients incapable of evaluating the NRS score)
  • Patients who did not give consent / did not want to participate

Treatment and study plan

Group QLB3

Procedure

Patients who applied the QLB3 block before PCNL surgery were included in this group

Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Other names: Anterior Quadratus Lumborum Block (QLB3)

Group ESPB

Procedure

Patients who applied ESP block before PCNL surgery were included in this group

Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Other names: Erector spina plane block (ESPB)

Group Control

Other

Patients who did not use block before PCNL surgery were included in this group.

Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Other names: Control

Primary outcomes

  1. Morphine consumption in the first 24 hours after surgery

    Time frame: postoperative day 1

    Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: postoperative day 1

    Pain status at rest and while activity will be assessed by numeric rating scale (NRS) score at 0, 3, 6, 12, 18, and 24 hours after surgery. In addition, the time until the first analgesic requirement will be recorded. The NRS is an 11-point numeric scale that ranges from 0 to 10.

  2. The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication.

    Time frame: postoperative day 1

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

  3. Intraoperative remifentanil consumption

    Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.

    The total amount of remifentanil consumed will be recorded.

  4. The number of patient required rescue analgesia

    Time frame: postoperative day 1

    The number of patients requiring rescue analgesics will be recorded over 24 hours.

  5. Time of first analgesic request

    Time frame: postoperative day 1

    Time at which the first analgesic is requested

  6. The number of patients with complications

    Time frame: Postoperative 7 days on an average

    The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded

  7. The mean arterial pressure

    Time frame: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.

    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

  8. The heart rate measurement

    Time frame: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.

    The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Comparison of the Effects of Anterior Quadratus Lumborum Block and Erector Spina Plane Block on Postoperative Acute Pain in Percutaneous Nephrolithotomy Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Dec 8, 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.

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