Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05924412
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2023-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parecoxib in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '24 hours', 'description': 'Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.'}], 'secondaryOutcomes': [{'measure': 'Basal quadriceps strength in the operative side', 'timeFrame': '1 hour before surgery', 'description': 'Leg extension strength measured with a handheld dynamometer'}, {'measure': 'Basal level of pain during leg extension in the operative side', 'timeFrame': '1 hour before surgery', 'description': 'Pain level measured with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Basal plasmatic creatinine', 'timeFrame': '1 hour before surgery', 'description': 'Plasmatic creatinine level measured in mg/dL from a blood sample'}, {'measure': 'Nerve block performance time', 'timeFrame': '5 minutes after anesthesia induction (before surgical incision)', 'description': 'Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks.'}, {'measure': 'Incidence of Block complications', 'timeFrame': '5 minutes after anesthesia induction and before surgical incision', 'description': 'Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms'}, {'measure': 'Time to first morphine dose request', 'timeFrame': '24 hours', 'description': 'Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device'}, {'measure': 'Morphine consumption during first 48 hours', 'timeFrame': '48 hours', 'description': 'Morphine consumed postoperatively during the first 48 hrs utilizing a patient-controlled analgesia device programmed 0.01mg/Kg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.'}, {'measure': 'Incidence of opioid related side effects', 'timeFrame': '48 hours', 'description': 'Report of nausea, vomitus, pruritus, urinary retention, respiratory depression'}, {'measure': 'Incidence of NSAIDs related clinical side effects', 'timeFrame': '48 hours', 'description': 'Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma'}, {'measure': 'Postoperative static pain level at 3 hours', 'timeFrame': '3 hours', 'description': 'Pain level measured at rest with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative dynamic pain level at 3 hours', 'timeFrame': '3 hours', 'description': 'Pain level measured during leg extension with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative static pain level at 6 hours', 'timeFrame': '6 hours', 'description': 'Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative dynamic pain level at 6 hours', 'timeFrame': '6 hours', 'description': 'Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative static pain level at 12 hours', 'timeFrame': '12 hours', 'description': 'Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative dynamic pain level at 12 hours', 'timeFrame': '12 hours', 'description': 'Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative static pain level at 24 hours', 'timeFrame': '24 hours', 'description': 'Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative dynamic pain level at 24 hours', 'timeFrame': '24 hours', 'description': 'Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative static pain level at 48 hours', 'timeFrame': '48 hours', 'description': 'Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Postoperative dynamic pain level at 48 hours', 'timeFrame': '48 hours', 'description': 'Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)'}, {'measure': 'Medial malleolus sensory block level', 'timeFrame': '3 hours', 'description': '0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch'}, {'measure': 'Lateral malleolus sensory block level', 'timeFrame': '3hours', 'description': '0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch'}, {'measure': 'Medial malleolus sensory block level', 'timeFrame': '24 hours', 'description': '0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch'}, {'measure': 'Lateral malleolus sensory block level', 'timeFrame': '24 hours', 'description': '0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch'}, {'measure': 'Postoperative quadriceps strength', 'timeFrame': '3 hours', 'description': 'Leg extension strength measured with a handheld dynamometer'}, {'measure': 'Postoperative quadriceps strength', 'timeFrame': '24 hours', 'description': 'Leg extension strength measured with a handheld dynamometer'}, {'measure': 'Incidence of restriction to perform physiotherapy', 'timeFrame': '6 hours', 'description': 'Inability to perform physiotherapy secondary to pain or motor blockade'}, {'measure': 'Incidence of restriction to perform physiotherapy', 'timeFrame': '24 hours', 'description': 'Inability to perform physiotherapy secondary to pain or motor blockade'}, {'measure': 'Incidence of restriction to perform physiotherapy', 'timeFrame': '48 hours', 'description': 'Inability to perform physiotherapy secondary to pain or motor blockade'}, {'measure': 'Postoperative plasmatic creatinine level', 'timeFrame': '48 hours', 'description': 'Plasmatic creatinine level measured in mg/dL from a blood sample'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Pain, Acute', 'Analgesia', 'Analgesic Nephropathy', 'Analgesic Adverse Reaction', 'Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '30536047', 'type': 'BACKGROUND', 'citation': 'Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.'}, {'pmid': '26827847', 'type': 'BACKGROUND', 'citation': "Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008."}, {'pmid': '32474417', 'type': 'BACKGROUND', 'citation': 'Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.'}, {'pmid': '24939863', 'type': 'BACKGROUND', 'citation': 'Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.'}, {'pmid': '12538372', 'type': 'BACKGROUND', 'citation': 'Hubbard RC, Naumann TM, Traylor L, Dhadda S. Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia. Br J Anaesth. 2003 Feb;90(2):166-72. doi: 10.1093/bja/aeg038.'}, {'pmid': '11589257', 'type': 'BACKGROUND', 'citation': 'Harris SI, Kuss M, Hubbard RC, Goldstein JL. Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. Clin Ther. 2001 Sep;23(9):1422-8. doi: 10.1016/s0149-2918(01)80117-x.'}, {'pmid': '11808971', 'type': 'BACKGROUND', 'citation': 'Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.'}, {'pmid': '27428259', 'type': 'BACKGROUND', 'citation': 'Seangleulur A, Vanasbodeekul P, Prapaitrakool S, Worathongchai S, Anothaisintawee T, McEvoy M, Vendittoli PA, Attia J, Thakkinstian A. The efficacy of local infiltration analgesia in the early postoperative period after total knee arthroplasty: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):816-831. doi: 10.1097/EJA.0000000000000516.'}, {'pmid': '25078268', 'type': 'BACKGROUND', 'citation': 'Affas F, Eksborg S, Wretenberg P, Olofsson C, Stephanson N, Stiller CO. Plasma concentration of ketorolac after local infiltration analgesia in hip arthroplasty. Acta Anaesthesiol Scand. 2014 Oct;58(9):1140-5. doi: 10.1111/aas.12371. Epub 2014 Jul 31.'}, {'pmid': '33197808', 'type': 'BACKGROUND', 'citation': 'Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.'}, {'pmid': '33990439', 'type': 'BACKGROUND', 'citation': 'Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.'}, {'pmid': '31985507', 'type': 'BACKGROUND', 'citation': 'Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available.'}, {'pmid': '29721648', 'type': 'BACKGROUND', 'citation': 'Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.'}]}, 'descriptionModule': {'briefSummary': 'Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA I - III BMI 20 - 35 (kg/m2)\n\nExclusion Criteria:\n\n* Adults who are not capable of giving their own consent\n* Pre-existing neuropathy (assessed in the history and physical examination)\n* Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)\n* Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)\n* Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)\n* Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib\n* Pregnancy\n* Chronic pain syndromes that require the use of opioids at home\n* Known history of sulfa allergy\n* History of ischemic heart disease\n* History of chronic gastritis or peptic ulcer'}, 'identificationModule': {'nctId': 'NCT05924412', 'briefTitle': 'Parecoxib in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'OAIC1308/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parecoxib', 'description': 'This arm will receive intravenous parecoxib in the intraoperative period.', 'interventionNames': ['Drug: Intravenous study drug']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group', 'interventionNames': ['Other: Intravenous saline solution']}], 'interventions': [{'name': 'Intravenous study drug', 'type': 'DRUG', 'description': '40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión', 'armGroupLabels': ['Parecoxib']}, {'name': 'Intravenous saline solution', 'type': 'OTHER', 'description': 'Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380420', 'city': 'Santiago', 'state': 'Metropolitan', 'country': 'Chile', 'facility': 'Hospital Clinico Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'deidentified data under reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Julian Aliste', 'investigatorAffiliation': 'University of Chile'}}}}