ESPB vs iPACK+ACB i total knäprotesplastik
Erector Spinae Plane Block vs. iPACK Block med Adductor Canal Block för smärtbehandling hos patienter som genomgår total knäbyte
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Poznań
-
Poznan, Poznań, Polen, 61-701
- Poznan University of Medical Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / 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
Andra namn:
Erector Spinae Plane Block
Andra namn:
|
|
Aktiv komparator: Erectro Spinae Plane Block
spinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine |
iPACK block + Adductor Canal Block
Andra namn:
Erector Spinae Plane Block
Andra namn:
|
|
Placebo-jämförare: Control group
Only spinal anesthesia - No peripheral nerve block |
only spinal anesthesia
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Opioid consumption
Tidsram: 48 hours after surgery
|
Total opiate consumption after surgery |
48 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to first rescue opiate analgesia
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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
Tidsram: 24 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
24 hours after surgery
|
|
Neutrophil-to-lymphocyte ratio
Tidsram: 48 hours after surgery
|
Neutrophil-to-lymphocyte ratio |
48 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Tidsram: 24 hours after surgery
|
Platelet-to-lymphocyte ratio |
24 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Tidsram: 48 hours after surgery
|
Platelet-to-lymphocyte ratio |
48 hours after surgery
|
|
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Studiestol: Łukasz Łapaj, Ph.D., Poznań University of Medical Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5/2024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Please provide the plan description
Tidsram för IPD-delning
6 month after study completion
Kriterier för IPD Sharing Access
from the corresponding author on the resonable request
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
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