Clinical Trial: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care"

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care

Brief Summary: Perineural injection of local anesthesic is currently the reference method for the treatment of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain is a dynamic phenomena in every patient. It is classified as intense during the first postoperative hours after surgery, and decreases in a non-linear manner over the days following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a decrease in adverse events related to the continuous infusion technique (motor or sensory blockade, paresthesia, etc.). The physician can also modify the pump settings according to the postoperative rehabilitation plan.The use of new communication techniques such as "telemedecine" may be of interest in reducing treatment onset time and optimizing pain management. The remote control consists to change the settings of the pump after if the anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain level, sensory and motor blockades. The physician goes to a dedicated website (Micrel CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio Service) connexion. The aim of this prospective, comparative, multicentric trial is to compare the effectiveness of patient management through two communication modalities: remote control versus bedside care.

Detailed Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome: Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings [ Time Frame: from arriving at the ward after surgery until 72 postoperative hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of nursing interventions [ Time Frame: from arriving at the ward after surgery until 72 postoperative hours ]
  • Duration of nursing interventions [ Time Frame: from arriving at the ward after surgery until 72 postoperative hours ]
  • Post operative pain measured by VAS (Visual Analog Scale) [ Time Frame: from before implementation of PCA until 72 postoperative hours ]
  • Amount of rescue analgesia [ Time Frame: from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours ]
  • Patient satisfaction Score at catheter removal (at 72 postoperative hours) [ Time Frame: at 72 postoperative hours ]
  • Time until the start of physical therapy [ Time Frame: from surgery until 72 postoperative hours ]
  • the physiotherapist's satisfaction scores [ Time Frame: at 72 postoperative hours ]
  • Healthcare staff (nurse and physician) satisfaction scores [ Time Frame: at 72 postoperative hours ]
  • Duration of hospital stay [ Time Frame: At the end of hospital stay (an expected average of 72 postoperative hours) ]
  • Overall cost of patient management strategy [ Time Frame: until end of postoperative patient management (an average of 72 postoperative hours) ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: December 10, 2013
Date Started: December 2013
Date Completion: December 2016
Last Updated: December 2, 2014
Last Verified: December 2014