Remote Controlled Analgesia on Patient Experience
Condition: Orthopaedic Surgery
Study type: Interventional

Summary: 
      The main objective of this study is to compare the efficacy of continuous nerve blocks with
      single injection in terms of perioperative patient satisfaction after scheduled orthopedic
      ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain
      Catastrophizing Scale (PCS) and type of surgery.

      Secondary objectives comprise the assessment of pain, readmission rates, patient
      mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about
      quality of recovery will be performed on day 1, about quality of life on day 45 and presence
      of neuropathic pain will be screened at 3 months. An economic study will also be conducted,
      including work resumption at 3 months.

      This is a multicentric prospective study. Three hundred patients will be randomized in two
      parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump
      versus single local anesthetics injection.

      The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary
      endpoints will include assessment of pain, opiates consumption, sensitivity and motricity
      scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and
      heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery
      (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4)
      at day 90.
    

Detailed description: 
      Acute postoperative pain is poorly treated. More than three-quarters of patients complain of
      pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks
      analgesia has proved effective among in-hospital patients but single injection strategy is
      easier to implement in the growing outpatient setting.

      The main objective of this study is to compare the efficacy of continuous nerve blocks with
      single injection in terms of perioperative patient satisfaction after scheduled orthopedic
      ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain
      Catastrophizing Scale (PCS) and type of surgery.

      Secondary objectives comprise the assessment of pain, readmission rates, patient
      mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about
      quality of recovery will be performed on day 1, about quality of life on day 45 and presence
      of neuropathic pain will be screened at 3 months. An economic study will also be conducted,
      including work resumption at 3 months.

      The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under
      general anesthesia with regional analgesia.

      Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability
      to complete a self-administered questionnaire, presenting American Society of Anesthesiology
      (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural
      catheter or a single injection of local anesthetics.

      This is a multicentric prospective study. Three hundred patients will be randomized in two
      parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump
      versus single local anesthetics injection.

      The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary
      endpoints will include assessment of pain, opiates consumption, sensitivity and motricity
      scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and
      heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery
      (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4)
      at day 90.
    

Intervention name(s): Remote-controlled perineural local anesthetics delivery
Intervention type(s): Other
Intervention description(s): Remote-controlled perineural local anesthetics delivery
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain Acute; Orthopedic Surgery; Satisfaction Nerve Blocks