Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE1
220 participants
INTERVENTIONAL
2025-08-01
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Uncontrolled systemic diseases.
3. Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
4. Gastrointestinal system disorders.
5. History of antiemetic and anticholinergic drug use.
6. 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.
7. Severe spinal deformities.
8. Infection at the puncture site.
9. Coagulation disorders.
10. Long-term use of sedatives and analgesic drugs before surgery.
11. Patients with mental illness or communication barriers.
12. Allergic to ropivacaine.
13. Participants involved in other clinical studies within the past 3 months.
14. History of previous lumbar surgeries.
15. Subjective unwillingness to participate in this study.
18 Years
80 Years
ALL
No
Sponsors
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Qianfoshan Hospital
OTHER
Responsible Party
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Guanghan Wu
Attending physician
Central Contacts
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References
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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.
Other Identifiers
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YXLL-KY-2023（101）
Identifier Type: -
Identifier Source: org_study_id
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