Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-04-17 @ 5:03 AM
Study NCT ID:
NCT02018068
Status:
TERMINATED
Last Update Posted:
2018-07-10
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care"
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MICREL
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 Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: