ESPB vs iPACK+ACB i total kneartroplastikk
Erector Spinae Plane Block vs. iPACK Block med Adductor kanalblokk for smertebehandling hos pasienter som gjennomgår total kneprotese
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Poznań
-
Poznan, Poznań, Polen, 61-701
- Poznan University of Medical Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 navn:
Erector Spinae Plane Block
Andre navn:
|
|
Aktiv komparator: Erectro Spinae Plane Block
spinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine |
iPACK block + Adductor Canal Block
Andre navn:
Erector Spinae Plane Block
Andre navn:
|
|
Placebo komparator: Control group
Only spinal anesthesia - No peripheral nerve block |
only spinal anesthesia
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Opioid consumption
Tidsramme: 48 hours after surgery
|
Total opiate consumption after surgery |
48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Łukasz Łapaj, Ph.D., Poznań University of Medical Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5/2024
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Please provide the plan description
IPD-delingstidsramme
6 month after study completion
Tilgangskriterier for IPD-deling
from the corresponding author on the resonable request
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .