- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07537647
The Effect of bılateral Erector spına Plan Block on postoperatıve paın ın spınal Surgery (ESPB)
The Effect of Bilateral Erector Spina Plan Block Performed After Lumbar Spinal Stabilization Surgery on Postoperative Patient Recovery and Pain
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Bursa
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Bursa, Bursa, Turkey (Türkiye), 16310
- Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye, BURSA, Bursa 16310
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:•
• Patients who volunteer to participate in the study
- Patients aged 18-65 years
- Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
- Patients who will undergo elective lumbar stabilization surgery
Exclusion Criteria:
• Patients who do not consent to participate in the study
- Patients with ASA physical status IV and V
- Patients using anticoagulant medications
- Patients with allergy to local anesthetic drugs
- Patients undergoing lumbar stabilization surgery at level three or higher
- Patients with a history of gastrointestinal bleeding
- Patients with a history of psychiatric illness (Major Depression, Schizophrenia, Bipolar Affective Disorder)
- Patients with narcotic drug and/or alcohol dependence
- Patients with a history of central and/or peripheral neurological disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESPB GROUP
Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine.
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In the ESP Block group, with the patient in the prone position, the research anesthesia team will insert a block needle through the skin one level above the surgical level using a linear probe guided by USG.
The needle will pass through the trapezius and erector spinae muscles, and upon reaching the transverse process (approximately 2-3 cm deep), a test dose of 0.5-1 mL of 0.9% NaCl will be applied between the erector spinae fascia and the vertebral transverse process to confirm needle placement.
After confirmation of fascial opening, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine.
This total volume will be diluted by half with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration.
The calculated local anesthetic solution will be applied to the erector spinae region for ESPB.
The same procedures will be performed on the opposite side.
Other Names:
For the ESP Block group, under USG guidance with the patient in prone position, a linear probe will be placed in the parasagittal plane one level above the operative level, and after visualizing the transverse process with an in-plane approach, a 50 mm long block needle will be inserted through the skin.
A test dose of 0.5-1 mL of 0.9% NaCl will be administered between the erector spinae fascia and the transverse process of the vertebra to confirm needle placement.
After confirming that the fascia has opened, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine.
This total volume will be diluted halfway with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration.
The calculated local anesthetic solution will be administered to the erector spinae area, and ESPB will be performed.
The same procedures will be performed on the opposite side.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POSTOPERATIVE PAIN SCORES
Time Frame: The Numerical rating scale (NRS) score will be applied at 0, 2, 4, 6, 12, and 24 hours postoperatively.Numerical rating scale (NRS), 0 to 10. Zero indicates the absence of pain, while ten indicates severe pain.
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Pain will be assessed using the Numerical rating scale (NRS) score at postoperatively.
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The Numerical rating scale (NRS) score will be applied at 0, 2, 4, 6, 12, and 24 hours postoperatively.Numerical rating scale (NRS), 0 to 10. Zero indicates the absence of pain, while ten indicates severe pain.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of postoperative analgesic consumption and hospital stay duration.
Time Frame: Postoperative 24-hour period
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As a secondary measure, the effect of bilateral erector spinae plane blocks performed after lumbar spinal stabilization surgery on analgesic use during the 24-hour postoperative period and total hospital stay will be evaluated. -Evaluation of analgesic consumption: Total Fentanyl (micrograms) Total Contromal (milligrams) Total Paracetamol (milligrams) Total dexketoprofen trometamol (milligrams) -Evaluation of total hospital stay (days). |
Postoperative 24-hour period
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUUKAEK-2024-4/4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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