The Relationship Between NLR and PONV and ESPB

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erector Spinae Plane Block; Neutrophil to Lymphocyte Ratio
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guanghan Wu, Attending physician; Phone Number: 18763995357; Email: GuanghanWu2021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Preoperative blood transfusion.
2. Uncontrolled systemic diseases.
3. Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
4. Gastrointestinal system disorders.
5. History of antiemetic and anticholinergic drug use.
6. 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.
7. Severe spinal deformities.
8. Infection at the puncture site.
9. Coagulation disorders.
10. Long-term use of sedatives and analgesic drugs before surgery.
11. Patients with mental illness or communication barriers.
12. Allergic to ropivacaine.
13. Participants involved in other clinical studies within the past 3 months.
14. History of previous lumbar surgeries.
15. Subjective unwillingness to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector Spinae Plane Block group(EA group + EB group); Conventional anesthesia induction, followed by ultrasound-guided erector spinae plane (ESPB) block with 0.5% ropivacaine (20 ml) after anesthesia induction.	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 contacts the bony transverse process and there is no blood or gas upon aspiration, 2-3 mL of isotonic saline solution is injected to confirm the correct needle position. Local anesthetic is then injected between the erector spinae muscle and the transverse process. The spread of the local anesthetic in the deep fascial plane within the erector spinae muscle can be visualized using ultrasound.
Sham Comparator: Control group（CA group + CB group); Conventional anesthesia induction, followed by ultrasound-guided injection of 0.9% saline (20 ml) into the erector spinae plane (ESPB) after anesthesia induction.	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 contacts the bony transverse process, and there is no blood or gas upon aspiration, 2-3 milliliters of isotonic saline solution are injected to confirm the correct needle position. Subsequently, 20 milliliters of 0.9% physiological saline is injected between the erector spinae muscle and the transverse process. The diffusion of the physiological saline in the deep fascial plane within the erector spinae muscle can be visualized using ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery.	Patients with a nausea and vomiting score of 1 point or above (0 points = no nausea, 1 point = nausea, 2 points = dry heaving, 3 points = vomiting) are treated with ondansetron as an antiemetic.	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.	Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.	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)	The neutrophil count and lymphocyte count and calculate the neutrophil-to-lymphocyte ratio (NLR).	Within the first 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall VAS (Visual Analog Scale) pain scores at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively during rest and movement.	VAS scoring criteria, also known as pain level scoring criteria, use a visual analog method to assess the severity of pain.The VAS (Visual Analog Scale) rating ranges from 0 to 10, with a VAS score of 0 indicating no pain. Scores of 1-3 represent mild pain (pain does not affect sleep), 4-6 indicate moderate pain (pain disrupts sleep), 7-9 correspond to severe pain (unable to fall asleep or waking up due to pain, or unable to sleep), and a score of 10 signifies excruciating pain. The higher the score, the more severe the pain.	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.	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.	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.	Record the time of the initial press of the patient-controlled analgesia pump.	Within the first 24 hours and the second 24 hours after surgery
Record the satisfaction scores for pain management at 24 and 48 hours.	Patient satisfaction score refers to the postoperative satisfaction level of the patient, with 0 points indicating dissatisfaction, 1 point indicating fair, 2 points indicating satisfaction, and 3 points indicating very satisfied. The higher the score, the more satisfied the patient is with the treatment outcome.	Within the first 24 hours and the second 24 hours after surgery
Record the postoperative awakening time.	Record the postoperative awakening time.	Within 24 hours.
Record the extubation time after surgery.	Record the extubation time after surgery.	Within 24 hours.
Postoperative stay in the PACU (Post-Anesthesia Care Unit).	Postoperative stay in the PACU (Post-Anesthesia Care Unit).	Within 24 hours.
Time of discharge post-surgery.	Time of discharge post-surgery.	Within 2 weeks.
Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.	Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.	Within 1 week
Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.	Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.	At 24 hours after surgery

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Postoperative analgesia; erector spinae plane block; Neutrophil to Lymphocyte Ratio; lumbosacral spine surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting
• Other Study ID Numbers: YXLL-KY-2023（101）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No