Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care" (MICREL)

University Hospital Center (CHU)

Status: Terminated

Conditions: Perineural Analgesia; Injury of Foot, Shoulder or Knee; Pain, Postoperative

Treatments: Other: At bedside care; Other: Remote control

Study type: Interventional

Funder types: Other

Identifiers

NCT02018068

9202

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Remote control

Experimental group

Description:

For patient randomized in arm "Remote Control", the communication with anesthesiologist will be done by teletransmission. The intervention "Remote control" is assigned to this arm. When evaluated pain values, sensory or motricity blockades are over the selected threshold then, the patient enters the data in the PCA (Patient Control Analgesia) pump, the physician in charge of the patient for the protocol is alerted by SMS on a specific smart phone and makes the necessary settings changes by Remote Control on the Micrel CareTM site.

Treatment:

Other: Remote control

At bedside care

Active Comparator group

Description:

For patient randomized in arm "At bedside care", the communication with the anesthesiologist in charge of the patient will be done via the nurses and referent physician of the medical unit, as a routine procedures. The necessary changes of pump settings are doing by the anesthesiologist. The intervention "at beside care" is assigned to arm "at bedside care".

Treatment:

Other: At bedside care