The Relationship Between NLR and PONV and ESPB
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQianfoshan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Preoperative blood transfusion.
Uncontrolled systemic diseases.
Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
Gastrointestinal system disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane Block
Procedure/SurgeryThe 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).
Procedure/SurgeryThe 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane Block group(EA group + EB group)Experimental treatment 1 intervention
Group B: Control group（CA group + CB group)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within the first 24 hours and the second 24 hours after surgery.2
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.
Time frame
Within the first 24 hours and the second 24 hours after surgery.3
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).
Time frame
Within the first 24 hours.Secondary outcomes
1
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.
Time frame
At 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery2
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.
Time frame
Within the first 24 hours and the second 24 hours after surgery3
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.
Time frame
Within the first 24 hours and the second 24 hours after surgery4
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.
Time frame
Within the first 24 hours and the second 24 hours after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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