Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-18 @ 10:49 PM
Study NCT ID:
NCT03063658
Status:
UNKNOWN
Last Update Posted:
2019-07-08
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'The first 24 hours after the completion of the surgery', 'description': 'Total morphine consumption during the 24 hours of early postoperative period'}], 'secondaryOutcomes': [{'measure': 'VAS scores', 'timeFrame': 'The first 24 hours after the completion of the surgery', 'description': 'VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period'}, {'measure': 'Morphine side effects', 'timeFrame': 'The first 24 hours after the completion of the surgery', 'description': 'Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ibuprofen', 'Paracetamol', 'Laparoscopic cholecystectomy', 'Morphine', 'Visual analog scale'], 'conditions': ['Acute Pain', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '20609131', 'type': 'BACKGROUND', 'citation': 'Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.'}, {'pmid': '27152748', 'type': 'BACKGROUND', 'citation': 'Gago Martinez A, Escontrela Rodriguez B, Planas Roca A, Martinez Ruiz A. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0154004. doi: 10.1371/journal.pone.0154004. eCollection 2016.'}, {'pmid': '25592331', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate two different analgesic regimen used for acute postoperative pain.', 'detailedDescription': 'Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.\n\nIbuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologist Functional Status 1-2\n2. Body mass index smaller than 30\n3. Undergoing laparoscopic cholecystectomy\n4. Age between 18-60 years\n\nExclusion Criteria:\n\n1. Age under 18, above 60\n2. Weight under 40 kg\n3. Body mass index above 30\n4. Contraindication for opioid and non-steroid anti-inflammatory drug usage\n5. Allergy against paracetamol, opioids and anti-inflammatory drugs\n6. Peptic ulcer\n7. Tendency to bleeding\n8. Pregnancy or breast feeding\n9. Moderate or severe renal, hepatic or cardiac insufficiency\n10. Coronary artery disease\n11. Asthma'}, 'identificationModule': {'nctId': 'NCT03063658', 'briefTitle': 'Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '16-827-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': 'Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': 'Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.', 'interventionNames': ['Drug: Ibuprofen 800 mg']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': 'The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.', 'armGroupLabels': ['Paracetamol']}, {'name': 'Ibuprofen 800 mg', 'type': 'DRUG', 'description': 'The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.', 'armGroupLabels': ['Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06660', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Neslihan Alkis, Prof', 'role': 'CONTACT', 'email': 'alkisneslihan@gmail.com', 'phone': '+905323435055'}], 'facility': 'Ankara University School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Menekse Ozcelik, M.D', 'role': 'CONTACT', 'email': 'ozcelikmenekse@yahoo.com', 'phone': '+905333521400'}], 'overallOfficials': [{'name': 'Zekeriyya Alanoglu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Department of Anesthesiology and Intensive Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Menekse Ozcelik', 'investigatorAffiliation': 'Ankara University'}}}}