Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02152592|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
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.
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
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).
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain After Ambulatory Surgery||Drug: PCM/Oxy1 Drug: PCM/Oxy2||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||March 2009|
No Intervention: PCM/NAPR group
paracetamol 1000 mg orally four times a day for 48 hours postoperatively and naproxen 500 mg orally twice a day for 48 hours postoperatively (standard hospital pain protocol for treatment of acute postoperative pain at home after painful day-case surgery)
Active Comparator: PCM/Oxy1 group
Controlled Release oxycodone 10 mg orally twice a day for 24 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively
Controlled Release oxycodone 10 mg orally twice a day for 24 hours
Active Comparator: PCM/Oxy2 group
CR oxycodone 10 mg orally twice a day for 48 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively
CR oxycodone 10 mg orally twice a day for 48 hours
- a difference on a pain visual analogue scale between study groups [ Time Frame: up to 48 hours ]a difference of 15mm or more on a visual analogue scale between three study groups is considered clinically relevant
- Incidence of adverse effects of study medication [ Time Frame: up to 48 hours ]
- Adherence to study medication [ Time Frame: up to 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152592
|Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands|