Sammenligning af den postoperative analgesiske effektivitet af klassiske og modificerede erector spinae-blokader efter lumbal spinalkirurgi
Sammenligning af effektiviteten af klassiske og modificerede Erector Spinae Plane-blokader i postoperativ smertebehandling efter lumbal ryggirurgi: Et prospektivt studie
The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Lumbar spinal stenosis may lead to variable signs and symptoms such as low back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques reduces opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing lumbar disc surgery, the classical erector spinae plane block and the modified erector spinae plane block provide effective analgesia for postoperative pain control.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Samsun, Tyrkiet (Türkiye)
- Samsun University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Exclusion Criteria:
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
- Inability to use a patient-controlled analgesia (PCA) device
- Suspected pregnancy, confirmed pregnancy, or breastfeeding Refusal to undergo the procedure or to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Active Comparator: Group K-ESP
The erector spinae plane block will be performed 30 minutes before lumbar spine surgery. |
The erector spinae plane block will be performed under ultrasound guidance before the induction of general anesthesia. |
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Aktiv komparator: Active Comparator: Group M-ESP
The modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery. |
Modified erector spinae plane blocks will be performed under ultrasound guidance before the induction of general anesthesia. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Opioid consumption
Tidsramme: 24 hours
|
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups. |
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perioperative pain intensity
Tidsramme: 24 hours
|
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain'). |
24 hours
|
|
Postoperative nausea and vomiting
Tidsramme: 24 hours
|
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting). |
24 hours
|
|
Quality of recovery 15 scale
Tidsramme: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale |
24 hours after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMUKAEK 2025/247
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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