Erector Spinae Plane BlockPhase 1NCT06127966
The Relationship Between NLR and PONV and ESPB
A Phase 1 study testing Erector Spinae Plane Block and 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB). in people with Erector Spinae Plane Block and Neutrophil to Lymphocyte Ratio, run by Qianfoshan Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Erector Spinae Plane Block, Neutrophil to Lymphocyte Ratio
- What is being tested?
- Erector Spinae Plane Block and 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Preoperative blood transfusion.
- Uncontrolled systemic diseases.
- Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
- Gastrointestinal system disorders.
- History of antiemetic and anticholinergic drug use.
- 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.
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- Severe spinal deformities.
- Infection at the puncture site.
- Coagulation disorders.
- Long-term use of sedatives and analgesic drugs before surgery.
- Patients with mental illness or communication barriers.
- Allergic to ropivacaine.
- Participants involved in other clinical studies within the past 3 months.
- History of previous lumbar surgeries.
- Subjective unwillingness to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Erector Spinae Plane Block, 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).
- Keywords
- Neutrophil to Lymphocyte Ratio, Postoperative Nausea and Vomiting, erector spinae plane block, Postoperative analgesia, lumbosacral spine surgery
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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).Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group(EA group + EB group) | Experimental | Conventional anesthesia induction, followed by ultrasound-guided erector spinae plane (ESPB) block with 0.5% ropivacaine (20 ml) after anesthesia induction. Receives: Procedure: Erector Spinae Plane Block |
| Control group（CA group + CB group) | Sham comparator | Conventional anesthesia induction, followed by ultrasound-guided injection of 0.9% saline (20 ml) into the erector spinae plane (ESPB) after anesthesia induction. Receives: Procedure: 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Within the first 24 hours.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within the first 24 hours and the second 24 hours after surgery
Record the postoperative awakening time.
Record the postoperative awakening time.
Measured: Within 24 hours.
Record the extubation time after surgery.
Record the extubation time after surgery.
Measured: Within 24 hours.
Postoperative stay in the PACU (Post-Anesthesia Care Unit).
Postoperative stay in the PACU (Post-Anesthesia Care Unit).
Measured: Within 24 hours.
Time of discharge post-surgery.
Time of discharge post-surgery.
Measured: 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.
Measured: 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.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghan Wu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127966
- Sponsor's protocol ID
- YXLL-KY-2023（101）
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang JJ, Wang Y, Li XF, Chen SS, Wang Y, Sun PY, Yang HK, Shi P, Wu G. The impact of erector spinae plane block on neutrophil-to-lymphocyte ratio and postoperative nausea and vomiting in lumbar spine surgery patients: a protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1630821. doi: 10.3389/fmed.2025.1630821. eCollection 2025.
PubMed 40950965
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06127966
- Acronym / sponsor ID
- YXLL-KY-2023（101）
- Keywords
- Neutrophil to Lymphocyte Ratio, Postoperative Nausea and Vomiting, erector spinae plane block, Postoperative analgesia, lumbosacral spine surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group(EA group + EB group) | Experimental | Procedure: Erector Spinae Plane BlockConventional anesthesia induction, followed by ultrasound-guided erector spinae plane (ESPB) block with 0.5% ropivacaine (20 ml) after anesthesia induction. |
| Control group（CA group + CB group) | Sham comparator | Procedure: 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB).Conventional anesthesia induction, followed by ultrasound-guided injection of 0.9% saline (20 ml) into the erector spinae plane (ESPB) after anesthesia induction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- Preoperative blood transfusion.
- Uncontrolled systemic diseases.
- Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
- Gastrointestinal system disorders.
- History of antiemetic and anticholinergic drug use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockThe 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. | Procedure or surgery | Erector Spinae Plane Block group(EA group + EB group) |
| 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. | Procedure or surgery | Control group（CA group + CB group) |
Primary outcome
Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery.
Time frame: 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.
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.
Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.
Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR)
Time frame: Within the first 24 hours.
The neutrophil count and lymphocyte count and calculate the neutrophil-to-lymphocyte ratio (NLR).
10 secondary outcomes
Overall VAS (Visual Analog Scale) pain scores at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively during rest and movement.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 24 hours and the second 24 hours after surgery
Record the satisfaction scores for pain management at 24 and 48 hours.
Time frame: Within the first 24 hours and the second 24 hours after surgery
Record the postoperative awakening time.
Time frame: Within 24 hours.
Record the extubation time after surgery.
Time frame: Within 24 hours.
Postoperative stay in the PACU (Post-Anesthesia Care Unit).
Time frame: Within 24 hours.
Time of discharge post-surgery.
Time frame: Within 2 weeks.
Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.
Time frame: Within 1 week
Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.
Time frame: At 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 40950965Wang JJ, Wang Y, Li XF, Chen SS, Wang Y, Sun PY, Yang HK, Shi P, Wu G. The impact of erector spinae plane block on neutrophil-to-lymphocyte ratio and postoperative nausea and vomiting in lumbar spine surgery patients: a protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1630821. doi: 10.3389/fmed.2025.1630821. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erector Spinae Plane Block and 0.9% physiological saline (20ml) injection under ultrasound-guided Erector Spinae Plane Block (ESPB). in people with Erector Spinae Plane Block and Neutrophil to Lymphocyte Ratio, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghan Wu, Attending physician (18763995357, GuanghanWu2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery. (time frame: Within the first 24 hours and the second 24 hours after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.