Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-29 @ 2:38 PM
Study NCT ID:
NCT02152592
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to study medication', 'timeFrame': 'up to 48 hours'}], 'primaryOutcomes': [{'measure': 'a difference on a pain visual analogue scale between study groups', 'timeFrame': 'up to 48 hours', 'description': 'a difference of 15mm or more on a visual analogue scale between three study groups is considered clinically relevant'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse effects of study medication', 'timeFrame': 'up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Ambulatory surgery', 'NSAIDS', 'CR Oxycodone', 'Compliance to study medication'], 'conditions': ['Postoperative Pain After Ambulatory Surgery']}, 'referencesModule': {'references': [{'pmid': '25516773', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur second goal is to assess analgesic adherence in the outpatient setting.\n\nEndpoints:\n\nPrimary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: - side-effects/ adverse effects of study medication\n\n* patient satisfaction with pain treatment\n* compliance to study medication\n\nStudy design:\n\nPatients 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.\n\nSubjects 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.\n\nRecovery 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.\n\nFinally, overall satisfaction with the postoperative pain treatment will be assessed (score 0-10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or laparoscopic inguinal hernia repair)\n* American Society of Anesthesiologists (ASA) physical classification I or II\n\nExclusion Criteria:\n\n* cognitive impairment,\n* preoperative pharmacologic pain treatment\n* allergy to or a contraindication for taking the study medication (e.g. paracetamol, oxycodone, naproxen or another NSAID)\n* porphyria\n* pregnancy or lactation\n* history of severe renal, hepatic, pulmonary, or cardiac failure\n* current symptoms or history of gastrointestinal bleeding, ileus or chronic obstipation\n* history of substance abuse, or use of medication with a suppressive effect on the central nervous system'}, 'identificationModule': {'nctId': 'NCT02152592', 'briefTitle': 'Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11524'}, 'secondaryIdInfos': [{'id': '2006-003545-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'PCM/NAPR group', 'description': '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)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCM/Oxy1 group', 'description': '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', 'interventionNames': ['Drug: PCM/Oxy1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCM/Oxy2 group', 'description': 'CR oxycodone 10 mg orally twice a day for 48 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively', 'interventionNames': ['Drug: PCM/Oxy2']}], 'interventions': [{'name': 'PCM/Oxy1', 'type': 'DRUG', 'description': 'Controlled Release oxycodone 10 mg orally twice a day for 24 hours', 'armGroupLabels': ['PCM/Oxy1 group']}, {'name': 'PCM/Oxy2', 'type': 'DRUG', 'description': 'CR oxycodone 10 mg orally twice a day for 48 hours', 'armGroupLabels': ['PCM/Oxy2 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bjorn Stessel', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}