The Relationship Between NLR and PONV and ESPB

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127966
Collaborator
(none)
220
2
22

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane Block
  • Procedure: 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery. [Within the first 24 hours and the 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.

  2. 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 need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.

  3. Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR) [Within the first 24 hours.]

    The neutrophil count and lymphocyte count and calculate the neutrophil-to-lymphocyte ratio (NLR).

Secondary Outcome Measures

  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. [At 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery]

    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.

  2. 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 patient's initial self-administration of the pain pump during the first 24 hours and the second 24 hours after surgery.

  3. 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 time of the initial press of the patient-controlled analgesia pump.

  4. Record the satisfaction scores for pain management at 24 and 48 hours. [Within the first 24 hours and the second 24 hours after surgery]

    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.

  5. Record the postoperative awakening time. [Within 24 hours.]

    Record the postoperative awakening time.

  6. Record the extubation time after surgery. [Within 24 hours.]

    Record the extubation time after surgery.

  7. Postoperative stay in the PACU (Post-Anesthesia Care Unit). [Within 24 hours.]

    Postoperative stay in the PACU (Post-Anesthesia Care Unit).

  8. Time of discharge post-surgery. [Within 2 weeks.]

    Time of discharge post-surgery.

  9. Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention. [Within 1 week]

    Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.

  10. Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day. [At 24 hours after surgery]

    Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guanghan Wu, Attending physician, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT06127966
Other Study ID Numbers:
  • YXLL-KY-2023(101)
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guanghan Wu, Attending physician, Qianfoshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023