Clinical trial NCT06127966: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Erector Spinae Plane Block
Neutrophil to Lymphocyte Ratio
Keywords: Neutrophil to Lymphocyte Ratio
Postoperative Nausea and Vomiting
erector spinae plane block
Postoperative analgesia
lumbosacral spine surgery
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery.
timeFrame: Within the first 24 hours and the second 24 hours after surgery.
measure: Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.
timeFrame: Within the first 24 hours and the second 24 hours after surgery.
measure: Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR)
timeFrame: Within the first 24 hours.
Secondary outcomes:
measure: Overall VAS (Visual Analog Scale) pain scores at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively during rest and movement.
timeFrame: At 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery
measure: 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.
timeFrame: Within the first 24 hours and the second 24 hours after surgery
measure: Record the time of the initial press of the patient-controlled analgesia pump.
timeFrame: Within the first 24 hours and the second 24 hours after surgery
measure: Record the satisfaction scores for pain management at 24 and 48 hours.
timeFrame: Within the first 24 hours and the second 24 hours after surgery
measure: Record the postoperative awakening time.
timeFrame: Within 24 hours.
measure: Record the extubation time after surgery.
timeFrame: Within 24 hours.
measure: Postoperative stay in the PACU (Post-Anesthesia Care Unit).
timeFrame: Within 24 hours.
measure: Time of discharge post-surgery.
timeFrame: Within 2 weeks.
measure: Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.
timeFrame: Within 1 week
measure: Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.
timeFrame: At 24 hours after surgery
Other outcomes:
Locations:
Study officials:
References: