Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
Condition: Postoperative Pain After Ambulatory Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      the primary objective of this study is to assess and compare the efficacy, safety and
      benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol
      (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful
      day-case surgery. We hypothesize that ambulatory patients postoperatively treated with
      oxycodone/paracetamol will achieve better pain relief with equal side effects compared to
      patients treated with paracetamol/naproxen.

      Our second goal is to assess analgesic adherence in the outpatient setting.

      Endpoints:

      Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: -
      side-effects/ adverse effects of study medication

        -  patient satisfaction with pain treatment

        -  compliance to study medication

      Study design:

      Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or
      laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial
      (RCT) at our pre-assessment clinic.

      Subjects will be enrolled by a study nurse and will be randomized into one of three study
      treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are assigned
      to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours
      postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally
      twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch CR
      oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol 1000
      mg orally four times a day for 48 hours postoperatively.

      Recovery after discharge will be assessed using a diary for up to 48 hours after surgery.
      Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea,
      vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore,
      compliance to the use of the study medication will be assessed by checking whether the
      patients took the study medication as prescribed and if any other pain medication was used.
      Compliance will be assessed three times a day and patients will be divided into three groups
      according to medication use: always = full compliance, sometimes = partial compliance, or
      never = no compliance.

      Finally, overall satisfaction with the postoperative pain treatment will be assessed (score
      0-10).
    


Intervention name(s): PCM/Oxy1; PCM/Oxy2
Intervention type(s): Drug; Drug
Intervention description(s): Controlled Release oxycodone 10 mg orally twice a day for 24 hours; CR oxycodone 10 mg orally twice a day for 48 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative pain; Ambulatory surgery; NSAIDS; CR Oxycodone; Compliance to study medication