The Relationship Between NLR and PONV and ESPB

Официальное название

The Relationship Between the Preoperative Neutrophil-to-lymphocyte Ratio (NLR) and Postoperative Nausea and Vomiting (PONV) in Lumbar Spine Surgery Patients, as Well as the Impact of Erector Spinae Plane Block on NLR and PONV

Обзор

This study aims to investigate whether preoperative NLR (Neutrophil-to-Lymphocyte Ratio) serves as a biomarker for PONV (Postoperative Nausea and Vomiting). It also examines the impact of erector spinae plane block on NLR and PONV. Furthermore, the research explores the effect of erector spinae plane block on postoperative pain relief in spinal surgery and its influence on the usage of opioid medications.

Вмешательства

• Процедура Erector Spinae Plane Block
  The patient assumes a prone position, and the appropriate lumbar vertebral level is identified using ultrasound, based on the preoperative markings of the surgical incision site. After disinfection, the ultrasound probe is placed in the parasagittal direction, 3 centimeters lateral to the midline, to identify the corresponding lumbar transverse process and the overlying erector spinae and latissimus dorsi muscles. Using an in-plane technique, the needle is advanced, and when the needle tip conta
• Процедура 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).
  The patient is placed in a prone position, and the appropriate lumbar vertebral level is determined using ultrasound based on the preoperative markings of the surgical incision site. After disinfection, the ultrasound probe is positioned in the parasagittal direction, 3 centimeters lateral to the midline, to identify the corresponding lumbar transverse process, erector spinae, and latissimus dorsi muscles above it. Using an in-plane technique, the needle is advanced, and when the needle tip cont

Первичные конечные точки

• Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery. [Срок оценки: Within the first 24 hours and the second 24 hours after surgery.]
• Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively. [Срок оценки: Within the first 24 hours and the second 24 hours after surgery.]
• Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR) [Срок оценки: Within the first 24 hours.]

Вторичные конечные точки (10)

• Overall VAS (Visual Analog Scale) pain scores at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively during rest and movement. [Срок оценки: At 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery]
• Record the time of the patient's initial self-administration of the pain pump during the first 24 hours and the second 24 hours after surgery. [Срок оценки: Within the first 24 hours and the second 24 hours after surgery]
• Record the time of the initial press of the patient-controlled analgesia pump. [Срок оценки: Within the first 24 hours and the second 24 hours after surgery]
• Record the satisfaction scores for pain management at 24 and 48 hours. [Срок оценки: Within the first 24 hours and the second 24 hours after surgery]
• Record the postoperative awakening time. [Срок оценки: Within 24 hours.]
• Record the extubation time after surgery. [Срок оценки: Within 24 hours.]
• Postoperative stay in the PACU (Post-Anesthesia Care Unit). [Срок оценки: Within 24 hours.]
• Time of discharge post-surgery. [Срок оценки: Within 2 weeks.]
• Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention. [Срок оценки: Within 1 week]
• Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day. [Срок оценки: At 24 hours after surgery]

Критерии участия

Критерии включения

• Patients undergoing elective posterior lumbar spine surgery in a prone position under general anesthesia.
• ASA classification grades I to II.
• Age between 18 and 80 years old.
• Signed the informed consent for this study.

Критерии исключения

• Preoperative blood transfusion.
• Uncontrolled systemic diseases.
• Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
• Gastrointestinal system disorders.
• History of antiemetic and anticholinergic drug use.
• History of adverse reactions related to surgery, deformity correction surgeries, defined as procedures involving instrumentation across three or more levels or aimed at correcting scoliosis or kyphosis.
• Severe spinal deformities.
• Infection at the puncture site.
• Coagulation disorders.
• Long-term use of sedatives and analgesic drugs before surgery.
• Patients with mental illness or communication barriers.
• Allergic to ropivacaine.
• Participants involved in other clinical studies within the past 3 months.
• History of previous lumbar surgeries.
• Subjective unwillingness to participate in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wang JJ, Wang Y, Li XF, Chen SS, Wang Y, Sun PY, Yang HK, Shi P, Wu G. The impact of erector spinae plane block on neutrophil-to-lymphocyte ratio and postoperative nausea and vomiting in lumbar spine surgery patients: a protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1630821. doi: 10.3389/fmed.2025.1630821. eCollection 2025. PMID 40950965

Идентификаторы

NCT: NCT06127966 · YXLL-KY-2023（101）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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