NCT02018068: MICREL

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

Terminated NA Last updated 10 July 2018

What this trial tests

NA trial testing Remote control in Injury of Foot, Shoulder or Knee in 72 participants. Terminated before completion.

Timeline

14 January 2014

Primary endpoint
27 July 2016

27 July 2016

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	72
Start date	14 January 2014
Primary completion	27 July 2016
Estimated completion	27 July 2016
Sites	4 locations across France, Netherlands, United Arab Emirates

Drugs / interventions tested

• Remote control
• At bedside care

Conditions studied

• Injury of Foot, Shoulder or Knee — all drugs for Injury of Foot, Shoulder or Knee →
• Perineural Analgesia — all drugs for Perineural Analgesia →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

University Hospital, Montpellier

Who can join

18 and older, any sex, with Injury of Foot, Shoulder or Knee or Perineural Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial.
   Capdevila X, Macaire P, Bernard N, Biboulet P, et al · · 2022 · PMID 34863052 · DOI 10.1016/j.jclinane.2021.110618