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

Pain, Postoperative Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02018068
• Other study ID #: 9202
• Status: Terminated
• Phase: N/A
• Start date: January 14, 2014
• Est. completion date: July 27, 2016

Study information

• Verified date: July 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: July 27, 2016
• Est. primary completion date: July 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Department of Anesthesiology and critical care, Lapeyronie University Hospital	Montpellier
France	Anesthesia Réanimation Department, Hôpital Saint Roch	Nice
Netherlands	A Schweitzer Hospital	Dordrecht
United Arab Emirates	Rachid Hospital	Dubaï

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Countries where clinical trial is conducted

France,  Netherlands,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings		from arriving at the ward after surgery until 72 postoperative hours
Secondary	Number of nursing interventions		from arriving at the ward after surgery until 72 postoperative hours
Secondary	Duration of nursing interventions		from arriving at the ward after surgery until 72 postoperative hours
Secondary	Post operative pain measured by VAS (Visual Analog Scale)		from before implementation of PCA until 72 postoperative hours
Secondary	Amount of rescue analgesia		from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours
Secondary	Patient satisfaction Score at catheter removal (at 72 postoperative hours)		at 72 postoperative hours
Secondary	Time until the start of physical therapy		from surgery until 72 postoperative hours
Secondary	the physiotherapist's satisfaction scores		at 72 postoperative hours
Secondary	Healthcare staff (nurse and physician) satisfaction scores		at 72 postoperative hours
Secondary	Duration of hospital stay		At the end of hospital stay (an expected average of 72 postoperative hours)
Secondary	Overall cost of patient management strategy		until end of postoperative patient management (an average of 72 postoperative hours)