ESPB vs iPACK+ACB i total knæarthroplastik
Erector Spinae Plane Block vs. iPACK-blok med Adductor-kanalblok til smertebehandling hos patienter, der gennemgår total knæudskiftning
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the surgery's induced stress response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.
This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Poznań
-
Poznan, Poznań, Polen, 61-701
- Poznan University of Medical Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.
Exclusion Criteria:
- patients who have a history of bleeding diathesis,
- take anticoagulant therapy,
- have a History of chronic pain before surgery,
- have Multiple trauma, cannot assess their pain (dementia),
- have been operated on under general anaesthesia,
- have an infection in the area and do not accept the procedure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: iPACK + ACB
spinal anesthesia + ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine) |
iPACK block + Adductor Canal Block
Andre navne:
Erector Spinae Plane Block
Andre navne:
|
|
Aktiv komparator: Erectro Spinae Plane Block
spinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine |
iPACK block + Adductor Canal Block
Andre navne:
Erector Spinae Plane Block
Andre navne:
|
|
Placebo komparator: Control group
Only spinal anesthesia - No peripheral nerve block |
only spinal anesthesia
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Opioid consumption
Tidsramme: 48 hours after surgery
|
Total opiate consumption after surgery |
48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to first rescue opiate analgesia
Tidsramme: 48 hours after procedure
|
Time after surgery when the patient needs opiate for the first time |
48 hours after procedure
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 4 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 4 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 8 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 8 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 12 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 12 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 16 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 16 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 20 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 20 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 24 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 24 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 36 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 36 hours after surgery
|
|
Numerical Rating Scale [range 0:10]
Tidsramme: Time Frame: 48 hours after surgery
|
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt) |
Time Frame: 48 hours after surgery
|
|
Neutrophil-to-lymphocyte ratio
Tidsramme: 24 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
24 hours after surgery
|
|
Neutrophil-to-lymphocyte ratio
Tidsramme: 48 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
48 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Tidsramme: 24 hours after surgery
|
Platelet-to-lymphocyte ratio |
24 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Tidsramme: 48 hours after surgery
|
Platelet-to-lymphocyte ratio |
48 hours after surgery
|
|
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Tidsramme: Postoperative 24 hours period
|
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating |
Postoperative 24 hours period
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Łukasz Łapaj, Ph.D., Poznań University of Medical Sciences
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
- 5/2024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Please provide the plan description
IPD-delingstidsramme
6 month after study completion
IPD-delingsadgangskriterier
from the corresponding author on the resonable request
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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