Injury of Foot, Shoulder or KneeMICRELNCT02018068
Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery by "Remote Control" Versus "Bedside Care"
A study testing At bedside care in people with Injury of Foot, Shoulder or Knee and Perineural Analgesia, run by University Hospital, Montpellier at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury of Foot, Shoulder or Knee, Perineural Analgesia, Pain, Postoperative
- What is being tested?
- At bedside care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Jan 2014to 27 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Protected patient
- Patient enrolled in another study
- Patient who can't understand local language
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Department of Anesthesiology and critical care, Lapeyronie University Hospital
Montpellier, 34295
Anesthesia Réanimation Department, Hôpital Saint Roch
Nice, 06001
About this study
Official title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care
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.
- Being tested
- Remote control, At bedside care
- Keywords
- Patient-controlled Perineural analgesia, Postoperative, Orthopedic surgery, "Remote Control" versus "at bedside care", Comparative medico-economic evaluation
- Medical subject headings
- Foot Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote controlOther
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.
At bedside careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote control | Experimental | 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. Receives: Other: Remote control |
| At bedside care | Active comparator | 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". Receives: Other: At bedside care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings
Measured: from arriving at the ward after surgery until 72 postoperative hours
Secondary outcomes (10)
Number of nursing interventions
Measured: from arriving at the ward after surgery until 72 postoperative hours
Duration of nursing interventions
Measured: from arriving at the ward after surgery until 72 postoperative hours
Post operative pain measured by VAS (Visual Analog Scale)
Measured: from before implementation of PCA until 72 postoperative hours
Amount of rescue analgesia
Measured: from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours
Patient satisfaction Score at catheter removal (at 72 postoperative hours)
Measured: at 72 postoperative hours
Time until the start of physical therapy
Measured: from surgery until 72 postoperative hours
the physiotherapist's satisfaction scores
Measured: at 72 postoperative hours
Healthcare staff (nurse and physician) satisfaction scores
Measured: at 72 postoperative hours
Duration of hospital stay
Measured: At the end of hospital stay (an expected average of 72 postoperative hours)
Overall cost of patient management strategy
Measured: until end of postoperative patient management (an average of 72 postoperative hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study start14 Jan 2014
- Primary completion27 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Foot, Shoulder or KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier XC CAPDEVILA, MD, PhD, Principal investigator, CHU Montpellier - Department of Anesthesiology and critical care, Lapeyronie University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018068
- Sponsor's protocol ID
- 9202
- Acronym
- MICREL
- Status last verified
- Jul 2018
- First submitted
- 10 Dec 2013
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34863052
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care
- ClinicalTrials.gov ID
- NCT02018068
- Acronym / sponsor ID
- MICREL / 9202
- Keywords
- Patient-controlled Perineural analgesia, Postoperative, Orthopedic surgery, "Remote Control" versus "at bedside care", Comparative medico-economic evaluation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote control | Experimental | Other: Remote controlFor 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. |
| At bedside care | Active comparator | Other: At bedside careFor 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote controlWhen 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. | Other | Remote control |
| At bedside careWhen 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. | Other | At bedside care |
Primary outcome
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
10 secondary outcomes
Number of nursing interventions
Time frame: from arriving at the ward after surgery until 72 postoperative hours
Duration of nursing interventions
Time frame: from arriving at the ward after surgery until 72 postoperative hours
Post operative pain measured by VAS (Visual Analog Scale)
Time frame: from before implementation of PCA until 72 postoperative hours
Amount of rescue analgesia
Time frame: from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours
Patient satisfaction Score at catheter removal (at 72 postoperative hours)
Time frame: at 72 postoperative hours
Time until the start of physical therapy
Time frame: from surgery until 72 postoperative hours
the physiotherapist's satisfaction scores
Time frame: at 72 postoperative hours
Healthcare staff (nurse and physician) satisfaction scores
Time frame: at 72 postoperative hours
Duration of hospital stay
Time frame: At the end of hospital stay (an expected average of 72 postoperative hours)
Overall cost of patient management strategy
Time frame: until end of postoperative patient management (an average of 72 postoperative hours)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Derived from this study: PubMed 34863052Capdevila 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier XC CAPDEVILA, MD, PhD principal investigator
CHU Montpellier - Department of Anesthesiology and critical care, Lapeyronie University Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At bedside care in people with Injury of Foot, Shoulder or Knee and Perineural Analgesia, run by University Hospital, Montpellier at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Netherlands, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.