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Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02152592
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bjorn Stessel, Maastricht University Medical Center

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).


Condition or disease Intervention/treatment Phase
Postoperative Pain After Ambulatory Surgery Drug: PCM/Oxy1 Drug: PCM/Oxy2 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: PCM/Oxy1
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
Drug: PCM/Oxy2
CR oxycodone 10 mg orally twice a day for 48 hours




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of adverse effects of study medication [ Time Frame: up to 48 hours ]

Other Outcome Measures:
  1. Adherence to study medication [ Time Frame: up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bjorn Stessel, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02152592     History of Changes
Other Study ID Numbers: 11524
2006-003545-17 ( EudraCT Number )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Bjorn Stessel, Maastricht University Medical Center:
Postoperative pain
Ambulatory surgery
NSAIDS
CR Oxycodone
Compliance to study medication

Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action