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

Primary Purpose

Injury of Foot, Shoulder or Knee, Perineural Analgesia, Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote control
At bedside care
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Injury of Foot, Shoulder or Knee focused on measuring Patient-controlled Perineural analgesia, Postoperative, Orthopedic surgery, "Remote Control" versus "at bedside care", Comparative medico-economic evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and critical care, Lapeyronie University Hospital
  • Anesthesia Réanimation Department, Hôpital Saint Roch
  • A Schweitzer Hospital
  • Rachid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote control

At bedside care

Arm 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.

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".

Outcomes

Primary Outcome Measures

Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings

Secondary Outcome Measures

Number of nursing interventions
Duration of nursing interventions
Post operative pain measured by VAS (Visual Analog Scale)
Amount of rescue analgesia
Patient satisfaction Score at catheter removal (at 72 postoperative hours)
Time until the start of physical therapy
the physiotherapist's satisfaction scores
Healthcare staff (nurse and physician) satisfaction scores
Duration of hospital stay
Overall cost of patient management strategy

Full Information

First Posted
December 10, 2013
Last Updated
July 6, 2018
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02018068
Brief Title
Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care"
Acronym
MICREL
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Study Start Date
January 14, 2014 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote control
Arm Type
Experimental
Arm 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.
Arm Title
At bedside care
Arm Type
Active Comparator
Arm 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".
Intervention Type
Other
Intervention Name(s)
Remote control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
At bedside care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of nursing interventions
Time Frame
from arriving at the ward after surgery until 72 postoperative hours
Title
Duration of nursing interventions
Time Frame
from arriving at the ward after surgery until 72 postoperative hours
Title
Post operative pain measured by VAS (Visual Analog Scale)
Time Frame
from before implementation of PCA until 72 postoperative hours
Title
Amount of rescue analgesia
Time Frame
from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours
Title
Patient satisfaction Score at catheter removal (at 72 postoperative hours)
Time Frame
at 72 postoperative hours
Title
Time until the start of physical therapy
Time Frame
from surgery until 72 postoperative hours
Title
the physiotherapist's satisfaction scores
Time Frame
at 72 postoperative hours
Title
Healthcare staff (nurse and physician) satisfaction scores
Time Frame
at 72 postoperative hours
Title
Duration of hospital stay
Time Frame
At the end of hospital stay (an expected average of 72 postoperative hours)
Title
Overall cost of patient management strategy
Time Frame
until end of postoperative patient management (an average of 72 postoperative hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier XC CAPDEVILA, MD, PhD
Organizational Affiliation
CHU Montpellier - Department of Anesthesiology and critical care, Lapeyronie University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and critical care, Lapeyronie University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Anesthesia Réanimation Department, Hôpital Saint Roch
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
A Schweitzer Hospital
City
Dordrecht
Country
Netherlands
Facility Name
Rachid Hospital
City
Dubaï
Country
United Arab Emirates

12. IPD Sharing Statement

Citations:
PubMed Identifier
34863052
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.
Results Reference
derived

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

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