Postoperative Pain After Ambulatory Surgery Clinical Trial
Official title:
Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
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).
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands | Maastricht |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adherence to study medication | up to 48 hours | No | |
| Primary | a difference on a pain visual analogue scale between study groups | a difference of 15mm or more on a visual analogue scale between three study groups is considered clinically relevant | up to 48 hours | No |
| Secondary | Incidence of adverse effects of study medication | up to 48 hours | No |