- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07652177
Comparison of the Analgesic Efficacy of Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Studieoversigt
Status
Detaljeret beskrivelse
Postoperative pain is commonly observed in patients undergoing lumbar microdiscectomy surgery.
To manage this pain, the lumbar erector spinae plane (ESP) block is frequently administered as part of a multimodal analgesia regimen, particularly with the aim of reducing opioid consumption in these patients.
Recent publications have demonstrated the analgesic efficacy of the sacral erector spinae plane block in lumbar microdiscectomy surgeries.
In this study, the postoperative analgesic effectiveness of the lumbar ESP block-performed two vertebral levels above the surgical site-will be compared with that of the sacral ESP block-performed two vertebral levels below the surgical site.
It is anticipated that this approach will provide effective analgesia while avoiding the use of opioids.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Gaziosmanpasa Research and Training Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
ASA I, ASA II, and ASA III patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Exclusion Criteria:
Pregnant patients
Patients who do not consent to the erector spinae plane block
Patients requiring mechanical ventilatory support
Patients with a history of substance abuse
Patients with a known allergy to the medications to be used
Patients with bleeding diathesis
Patients with infection at the planned block site
Patients undergoing surgical intervention at two or more spinal levels
Patients with communication difficulties or intellectual disabilities
Patients with neuropsychiatric disorders
Patients with chronic pain
Patients with an expected surgical duration of 180 minutes or more
Patients with a prior history of lumbar microdiscectomy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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lumbar ESP
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sacral ESP
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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total tramadol consumption
Tidsramme: first 24 hours after the surgery
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first 24 hours after the surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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patients' visual analog scale
Tidsramme: first 24 hours after the surgery
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To compare postoperative Visual Analog Scale (VAS) pain scores at 2, 4, 8, 12, and 24 hours.
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first 24 hours after the surgery
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To compare analgesic consumption during the postoperative time intervals of 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
Tidsramme: first 24 hours after the surgery
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postoperative 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
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first 24 hours after the surgery
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GaziosmanpasaEAH LomberESP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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