Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- a difference on a pain visual analogue scale between study groups
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or laparoscopic inguinal hernia repair)
- •American Society of Anesthesiologists (ASA) physical classification I or II
Exclusion Criteria
- •cognitive impairment,
- •preoperative pharmacologic pain treatment
- •allergy to or a contraindication for taking the study medication (e.g. paracetamol, oxycodone, naproxen or another NSAID)
- •porphyria
- •pregnancy or lactation
- •history of severe renal, hepatic, pulmonary, or cardiac failure
- •current symptoms or history of gastrointestinal bleeding, ileus or chronic obstipation
- •history of substance abuse, or use of medication with a suppressive effect on the central nervous system
Arms & Interventions
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
Intervention: PCM/Oxy1 (Drug)
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
Intervention: PCM/Oxy2 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Incidence of adverse effects of study medication(up to 48 hours)
Investigators
Bjorn Stessel
MD
Maastricht University Medical Center