Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Remote control (Other)
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".
干预措施: At bedside care (Other)
结局指标
主要结局
Time between the patient's call and the change in Patient Control Analgesia (PCA) pump settings
时间窗: from arriving at the ward after surgery until 72 postoperative hours
次要结局
- Number of nursing interventions(from arriving at the ward after surgery until 72 postoperative hours)
- Duration of nursing interventions(from arriving at the ward after surgery until 72 postoperative hours)
- Post operative pain measured by VAS (Visual Analog Scale)(from before implementation of PCA until 72 postoperative hours)
- Amount of rescue analgesia(from implementation of PCA (Patient Control Analgesia) until 72 postoperative hours)
- Patient satisfaction Score at catheter removal (at 72 postoperative hours)(at 72 postoperative hours)
- Time until the start of physical therapy(from surgery until 72 postoperative hours)
- the physiotherapist's satisfaction scores(at 72 postoperative hours)
- Healthcare staff (nurse and physician) satisfaction scores(at 72 postoperative hours)
- Duration of hospital stay(At the end of hospital stay (an expected average of 72 postoperative hours))
- Overall cost of patient management strategy(until end of postoperative patient management (an average of 72 postoperative hours))