The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty. (HOBSALIplus)
The Effect of Saphenous Nerve and Obturator Nerve Block Combined With Systemic High Dose Glucocorticoid Versus Local Infiltration Analgesia Combined With a Systemic High Dose Glucocorticoid on Opioid Consumption and Pain After Total Knee Arthroplasty
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of two treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).
- B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age> 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- ASA 1-3
Exclusion Criteria:
- Patients who can not cooperate with the investigation
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients receiving glucocorticoid daily
- Patients with a treatment-dependent diabetes mellitus
- Patients with known neuropathy in the lower limbs
- Allergy to those used in the study drugs
- Alcohol and / or drug abuse - the investigator's opinion
- Patients who can not tolerate NSAIDs
- Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Combined nerve block
Ropivacaine and Adrenalin, systemic Ketorolac and high dose Dexamethasone
|
Altri nomi:
|
|
Comparatore attivo: Local infiltrationanalgesia
Ropivacaine, Adrenalin and Ketorolac combined with systemic high dose dexamethasone
|
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Opioid consumption
Lasso di tempo: 0 - 20 hours postoperatively
|
0 - 20 hours postoperatively
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Opioid consumption
Lasso di tempo: 0 - 24 hours postoperatively
|
0 - 24 hours postoperatively
|
|
|
Pain Score by passive flexion of the knee joint from 0-90 degrees.
Lasso di tempo: At timepoint 2 , 6, 20 and 24 hours postoperatively
|
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
|
At timepoint 2 , 6, 20 and 24 hours postoperatively
|
|
Pain score at rest
Lasso di tempo: At timepoint 2 , 6, 20 and 24 hours postoperatively
|
Using NRS (numeric rating scale) values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.
The highest score since last score recorded.
|
At timepoint 2 , 6, 20 and 24 hours postoperatively
|
|
Time of initial postoperative opioid-required pain breakthrough ( NRS > 3 at rest)
Lasso di tempo: 0-24 hours postoperatively
|
Recorded at PCA(patient-controlled-analgesia) pump
|
0-24 hours postoperatively
|
|
Nausea Score
Lasso di tempo: At timepoint 2, 6, 20, 24 hours postoperatively
|
NRS (numeric rating scale ) - with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea.
The highest score since last score recorded.
|
At timepoint 2, 6, 20, 24 hours postoperatively
|
|
Number of vomiting
Lasso di tempo: 0- 20 hours and 0-24 hours postoperatively
|
0- 20 hours and 0-24 hours postoperatively
|
|
|
Consumption of Ondansetron
Lasso di tempo: 0-20 hours and 0-24 hours
|
0-20 hours and 0-24 hours
|
|
|
Reporting of dizziness Recording whether the dizziness is preventing mobilization.
Lasso di tempo: at timepoint 2, 6, 20 and 24 hours postoperatively.
|
Recording whether the dizziness is preventing
|
at timepoint 2, 6, 20 and 24 hours postoperatively.
|
|
Duration of stay (length of stay , LOS ) in the observation unit (post anesthesia care unit , pacu).
Lasso di tempo: 0-24 hours postoperatively
|
The end time for the LOS in PACU recorded at the time when the patient meets DASAIMs (Danish Society of Anaesthesiology and Intensive Therapy) printing criteria - regardless of Pacu 's logistics in general.
|
0-24 hours postoperatively
|
|
Discharge time from the hospital
Lasso di tempo: maximum 60 hour postoperatively.
|
maximum 60 hour postoperatively.
|
|
|
Preoperatively isometric tests of muscle strength in the hip adductors.
Lasso di tempo: pre and 30 minutes after block placement
|
Performed by a handheld dynamometer before and 30 minutes after performed nerve blockades.
The patient performed 4-10 measurements with a 30 second break in between each measurement.
The difference between the highest value for the test before and after nerve block is calculated.
|
pre and 30 minutes after block placement
|
|
Time where the patient first time are mobilize to walk postoperatively with crutches or support from nurses.
Lasso di tempo: 0-24 hours posteratively
|
0-24 hours posteratively
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Charlotte Runge, MD, Regionalhospital Silkeborg
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Anestetici
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della ciclossigenasi
- Agenti antineoplastici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Anestetici, Locali
- Desametasone
- Ketorolac
- Ropivacaina
Altri numeri di identificazione dello studio
- 2014-003343-35
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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