The Relationship Between NLR and PONV and ESPB

Erector Spinae Plane Block Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127966
• Other study ID #: YXLL-KY-2023(101)
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: Guanghan Wu, Attending physician
• Phone: 18763995357
• Email: GuanghanWu2021[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Gastrointestinal system disorders.

4. History of antiemetic and anticholinergic drug use.

5. Adverse reactions related to surgery.

6. Severe spinal deformities.

7. Infection at the puncture site.

8. Coagulation disorders.

9. Long-term use of sedatives and analgesic drugs before surgery.

10. Patients with mental illness or communication barriers.

11. Allergic to ropivacaine.

12. Participants involved in other clinical studies within the past 3 months.

13. History of previous lumbar surgeries.

14. Subjective unwillingness to participate in this study.

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Postoperative Nausea and Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Record the postoperative awakening time.	Record the postoperative awakening time.	Within 24 hours.
Secondary	Record the extubation time after surgery.	Record the extubation time after surgery.	Within 24 hours.
Secondary	Postoperative stay in the PACU (Post-Anesthesia Care Unit).	Postoperative stay in the PACU (Post-Anesthesia Care Unit).	Within 24 hours.
Secondary	Time of discharge post-surgery.	Time of discharge post-surgery.	Within 2 weeks.
Secondary	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
Secondary	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