The Relationship Between NLR and PONV and ESPB

Official title

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

Overview

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.

Interventions

• Procedure 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
• Procedure 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

Primary outcome measures

• Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery. [Time frame: 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. [Time frame: 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) [Time frame: Within the first 24 hours.]

Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: Within the first 24 hours and the second 24 hours after surgery]
• Record the satisfaction scores for pain management at 24 and 48 hours. [Time frame: Within the first 24 hours and the second 24 hours after surgery]
• Record the postoperative awakening time. [Time frame: Within 24 hours.]
• Record the extubation time after surgery. [Time frame: Within 24 hours.]
• Postoperative stay in the PACU (Post-Anesthesia Care Unit). [Time frame: Within 24 hours.]
• Time of discharge post-surgery. [Time frame: Within 2 weeks.]
• Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention. [Time frame: Within 1 week]
• Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day. [Time frame: At 24 hours after surgery]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT06127966 · YXLL-KY-2023（101）

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗