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Clinical Trials/NCT02018068
NCT02018068
Terminated
Not Applicable

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

University Hospital, Montpellier4 sites in 3 countries72 target enrollmentJanuary 14, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Injury of Foot, Shoulder or Knee
Sponsor
University Hospital, Montpellier
Enrollment
72
Locations
4
Primary Endpoint
Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2014
End Date
July 27, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for elective orthopedic surgery
  • Patients older than 18 years old
  • Patient with a surgical indication (foot, shoulder or knee) which can require placement of a perineural catheter
  • Patients classified ASA class I to III
  • Informed consent

Exclusion Criteria

  • Contraindication to regional anesthesia or local anesthetics
  • Contraindication to paracetamol, ketoprofen or morphine (depending on the selected rescue analgesia)
  • Hospital discharge less than 48 hours after surgery
  • Psychomotor disease (teletransmission contraindication)
  • Patient undergoing surgery with a duration greater than 4 hours
  • Patient with a duration of perineural catheter less than 48 hours
  • Protected patient
  • Patient enrolled in another study
  • Patient who can't understand local language

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Study Sites (4)

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