Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
2 other identifiers
interventional
105
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
June 2, 2014
CompletedJune 2, 2014
May 1, 2014
1.4 years
May 28, 2014
May 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Incidence of adverse effects of study medication
up to 48 hours
Other Outcomes (1)
Adherence to study medication
up to 48 hours
Study Arms (3)
PCM/NAPR group
NO INTERVENTIONparacetamol 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)
PCM/Oxy1 group
ACTIVE COMPARATORControlled Release oxycodone 10 mg orally twice a day for 24 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively
PCM/Oxy2 group
ACTIVE COMPARATORCR oxycodone 10 mg orally twice a day for 48 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands
Maastricht, Netherlands
Related Publications (1)
Stessel B, Theunissen M, Fiddelers AA, Joosten EA, Kessels AG, Gramke HF, Marcus MA. Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial. Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.
PMID: 25516773DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 28, 2014
First Posted
June 2, 2014
Study Start
October 1, 2007
Primary Completion
March 1, 2009
Last Updated
June 2, 2014
Record last verified: 2014-05