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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02018068
First received: December 10, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Injury of Foot, Shoulder or Knee,
Perineural Analgesia
Pain, Postoperative
Other: Remote control
Other: At bedside care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of nursing interventions [ Time Frame: from arriving at the ward after surgery until 72 postoperative hours ] [ Designated as safety issue: No ]
  • Duration of nursing interventions [ Time Frame: from arriving at the ward after surgery until 72 postoperative hours ] [ Designated as safety issue: No ]
  • Post operative pain measured by VAS (Visual Analog Scale) [ Time Frame: from before implementation of PCA until 72 postoperative hours ] [ Designated as safety issue: No ]
  • Amount of rescue analgesia [ Time Frame: from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours ] [ Designated as safety issue: No ]
  • Patient satisfaction Score at catheter removal (at 72 postoperative hours) [ Time Frame: at 72 postoperative hours ] [ Designated as safety issue: No ]
  • Time until the start of physical therapy [ Time Frame: from surgery until 72 postoperative hours ] [ Designated as safety issue: No ]
  • the physiotherapist's satisfaction scores [ Time Frame: at 72 postoperative hours ] [ Designated as safety issue: No ]
  • Healthcare staff (nurse and physician) satisfaction scores [ Time Frame: at 72 postoperative hours ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: At the end of hospital stay (an expected average of 72 postoperative hours) ] [ Designated as safety issue: No ]
  • Overall cost of patient management strategy [ Time Frame: until end of postoperative patient management (an average of 72 postoperative hours) ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote control
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.
Other: Remote control
When pain or sensory and motor block evaluation exceed the thresholds, the patient enters the data in the PCA (patient Control Analgesia) pump. The investigator is alerted by SMS on his smartphone and makes the necessary programming changes by remote control on the Micrel Care TM site. Systematic assessments via the PCA pump are scheduled for 9:00, 13:00 and 19:00 every day during 48 to 72 hours. The patient can alert his physician through his PCA pump of any additional requests (pain, motor blockade, numbness). The anesthesiologist receives an SMS alert and can make any necessary programming changes to the pump via the remote control.
Active Comparator: At bedside care
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".
Other: At bedside care
When pain or sensory and motor block evaluation exceed the thresholds, the nurse contacts the physician and she will be able to modify the pump settings according to the anesthesiologist prescription. The delay between the call of the patient and the programming changes, the duration of the procedure are reported. Systematic evaluations via the PCA (Patient Control Analgesia) pump are done when the patient arrives in this surgical ward and at 9:00, 13:00 and 19:00 every day for 48 to 72 hours.Throughout the study, if necessary, the nurse or referring physician performs the programming changes directly on the PCA pump and notes the delay in treatment. All the reasons and the duration of any bedside visit are reported.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018068

Contacts
Contact: Xavier XC CAPDEVILA, MD, PhD +3367338256 x-capdevila@chu-montpellier.fr
Contact: Sophie SB BRINGUIER-BRANCHEREAU +3367338256 s-bringuierbranchereau@chu-montpellier.fr

Locations
France
Department of Anesthesiology and critical care, Lapeyronie University Hospital Not yet recruiting
Montpellier, France, 34295
Contact: Xavier XC CAPDEVILA, MD, PhD    +33467338256    x-capdevila@chu-montpellier.fr   
Contact: Sophie SB BRINGUIER-BRANCHEREAU    +33467338256    s-bringuierbranchereau@chu-montpellier.fr   
Principal Investigator: Xavier XC CAPDEVILA, MD, PhD         
Anesthesia Réanimation Department, Hôpital Saint Roch Not yet recruiting
Nice, France, 06001
Contact: Michel MC CARLES, MD, PhD    +33637377443    carles.m@chu-nice.fr   
Principal Investigator: Michel MC CARLES, MD, PhD         
Netherlands
A Schweitzer Hospital Not yet recruiting
Dordrecht, Netherlands
Contact: Xavier XF FALIERES, MD         
Principal Investigator: Xavier XF FALIERES, MD         
United Arab Emirates
Rachid Hospital Not yet recruiting
Dubaï, United Arab Emirates
Contact: Philippe PM MACAIRE, MD    +971509244789    ph.macaire@gmail.com   
Principal Investigator: Philippe PM MACAIRE, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Xavier XC CAPDEVILA, MD, PhD CHU Montpellier - Department of Anesthesiology and critical care, Lapeyronie University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02018068     History of Changes
Other Study ID Numbers: UF9202
Study First Received: December 10, 2013
Last Updated: December 16, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Patient-controlled Perineural analgesia
Postoperative
Orthopedic surgery
"Remote Control" versus "at bedside care"
Comparative medico-economic evaluation

Additional relevant MeSH terms:
Foot Injuries
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Leg Injuries
Wounds and Injuries
Benzethonium
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014