Clinical trial NCT02018068: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care"
Official title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Injury of Foot, Shoulder or Knee
Perineural Analgesia
Pain, Postoperative
Keywords: Patient-controlled Perineural analgesia
Postoperative
Orthopedic surgery
"Remote Control" versus "at bedside care"
Comparative medico-economic evaluation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings
timeFrame: from arriving at the ward after surgery until 72 postoperative hours
Secondary outcomes:
measure: Number of nursing interventions
timeFrame: from arriving at the ward after surgery until 72 postoperative hours
measure: Duration of nursing interventions
timeFrame: from arriving at the ward after surgery until 72 postoperative hours
measure: Post operative pain measured by VAS (Visual Analog Scale)
timeFrame: from before implementation of PCA until 72 postoperative hours
measure: Amount of rescue analgesia
timeFrame: from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours
measure: Patient satisfaction Score at catheter removal (at 72 postoperative hours)
timeFrame: at 72 postoperative hours
measure: Time until the start of physical therapy
timeFrame: from surgery until 72 postoperative hours
measure: the physiotherapist's satisfaction scores
timeFrame: at 72 postoperative hours
measure: Healthcare staff (nurse and physician) satisfaction scores
timeFrame: at 72 postoperative hours
measure: Duration of hospital stay
timeFrame: At the end of hospital stay (an expected average of 72 postoperative hours)
measure: Overall cost of patient management strategy
timeFrame: until end of postoperative patient management (an average of 72 postoperative hours)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital
city: Nice
country: France
facility: Anesthesia Réanimation Department, Hôpital Saint Roch
city: Dordrecht
country: Netherlands
facility: A Schweitzer Hospital
city: Dubaï
country: United Arab Emirates
facility: Rachid Hospital
Study officials:
affiliation: CHU Montpellier - Department of Anesthesiology and critical care, Lapeyronie University Hospital
name: Xavier XC CAPDEVILA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capdevila X, Macaire P, Bernard N, Biboulet P, Cuvillon P, Choquet O, Bringuier S. Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial. J Clin Anesth. 2022 May;77:110618. doi: 10.1016/j.jclinane.2021.110618. Epub 2021 Dec 1.