Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Replacement

27 settembre 2016 aggiornato da: Brian M. Ilfeld, MD, MS, University of California, San Diego

Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Arthroplasty: A Multicenter, Randomized, Triple-Masked, Placebo-Controlled Investigation

To determine if following total knee replacement, putting local anesthetic-or numbing medication-for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  1. Procedures that will be done as part of your normal clinical care (even if you do not participate in this research):

    You will have some monitors placed (such as a blood-pressure cuff) and be given some medicines through your intravenous line to make you very sleepy. The anesthesiologist will then place a tiny tube, called a catheter, near your nerves that will be used during and following surgery. This involves carefully cleaning the immediate area in the upper thigh where the catheter will be placed, numbing the site of the catheter with local anesthetic placed just under the skin, placing a needle through the skin that is numbed to an area near where your nerves are, putting the catheter through the needle so that the tip is next to your nerves, then removing the needle leaving the catheter in place. You can still go to sleep for the surgery, but you will be more comfortable when you wake up because the numbing medicine will be working to take away much of the pain. If you are not part of this study, you would go from the recovery room to a room in the hospital for 3-5 days, and your catheter would probably be removed the morning after surgery. After removal of your catheter, you would depend on oral and intravenous pain medicine ("opioids"-like morphine) to control your surgical pain. You would go home with only oral opioids since intravenous opioids cannot be provided at home.

  2. Procedures that will be done only if you participate in this research study:

    From the recovery room you will go to the surgical ward. During your stay in the hospital you will have the ability to push a button on a small infusion pump-a little device that holds and puts the medicine through the catheter to bath your nerves in local anesthetic-to give yourself more medicine through the tube to your nerves if you have pain. If this does not help enough, you will take pain pills to help. And if this does not help enough, you will be given opioids (strong pain medicine like morphine) into your intravenous line.

  3. On the morning after surgery, the medicine in your little infusion pump will be replaced by either (1) more medicine, or (2) salt water, or "normal saline". The pharmacist will determine this randomly-like flipping a coin-and neither you nor the doctors/nurses caring for you will know which you have. This is to keep any of us from inadvertently/ unconsciously affecting the results of the study.
  4. You will undergo physical therapy and following this you will be checked to see if you are ready to go home. This will include walking in the morning and afternoon with a physical therapist. When you are ready to go home beginning on the third day after surgery, you may go home with the little infusion pump and the tube that delivers the fluid. You will be given a prescription for pain pills in case you need them for pain relief.
  5. One of the study investigators will call you each night to ensure that you are comfortable for the first 6 nights after your surgery, and you will be given the phone and pager numbers of your physician (anesthesiologist) available for you to contact 24 hours/day, 7 days/week. A research nurse will call you for five nights beginning the day after surgery to ask about your comfort level and other study-related information such as your satisfaction level.
  6. On the fourth evening following surgery your catheter will be removed. You have two options available to you to remove your catheter. You can call a physician who will talk you or your caregiver through this process over the phone--it will not hurt or bleed. Your other option is to come back to the hospital to have a health care professional remove the catheter for you. The pump, catheter and remaining fluid are disposable and will not hurt people or pets, so they will be thrown away. A physician will call you the night after the catheter comes out to ensure that you are comfortable.
  7. A research nurse will call you at 7 days and then 1, 2, 3, 6, and 12 months following your surgery. Each of these calls will be less than five minutes in length during which time you will be asked questions about your levels of pain, stiffness and joint functional ability. Your participation will be limited to 12 months after surgery with these phone calls.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

81

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre
  • Stati Uniti
    • California
      • Berkeley, California, Stati Uniti, 94705
        • Alta Bates Summit Medical Center
      • San Diego, California, Stati Uniti, 92103
        • University of California San Diego
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. undergoing primary, unilateral knee replacement
  2. age 18 - 75 years
  3. postoperative analgesic plan includes perineural local anesthetic infusion and
  4. the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal.

Exclusion Criteria:

  1. morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
  2. renal insufficiency (preoperative creatinine > 1.5 mg/dL)
  3. chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  4. history of opioid abuse and
  5. any comorbidity which results in moderate or severe functional limitation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Prolonged infusion
At least 100 hours of femoral perineural ropivacaine infusion.
Procedura: Ambulatory continuous femoral nerve block for 100 hours
Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.
Comparatore placebo: Standard-of-Care
Overnight femoral perineural ropivacaine infusion followed by a femoral perineural normal saline infusion (placebo) until postoperative day 4.
Procedura: Ambulatory continuous femoral nerve block for 100 hours
Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
The time from surgical stop until patients meet three readiness-for-discharge criteria (adequate analgesia, free of intravenous opioids for 12 hours, able to ambulate at least 30 meters).
Lasso di tempo: Twice daily until hospital discharge
Twice daily until hospital discharge

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Quality-of-life as measured with the Western Ontario McMasters University questionnaire (WOMAC) up to 1 year postoperatively.
Lasso di tempo: preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively
preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively
In addition, we will evaluate daily pain scores; (2) daily oral and intravenous opioid requirements; (3) sleep quality and disturbances; (4) knee flexion and extension; and (5) patient satisfaction.
Lasso di tempo: Daily until 6 days postoperatively
Daily until 6 days postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Diego

Collaboratori

University of Florida
Stryker Instruments

Investigatori

  • Investigatore principale: Brian M Ilfeld, MD, MS, University of California, San Diego

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2007

Completamento primario (Effettivo)

1 agosto 2010

Completamento dello studio (Effettivo)

1 agosto 2010

Date di iscrizione allo studio

Primo inviato

4 gennaio 2007

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2007

Primo Inserito (Stima)

8 gennaio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 settembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2016

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • PAINfRE TKA Investigation
  • 1K23GM077026-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

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 .

Prove cliniche su Protesi totale di ginocchio

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Japan

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi