Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty
NCT ID: NCT04414995
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
36 participants
INTERVENTIONAL
2020-06-05
2020-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
Patients in Group 2 received 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation followed by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
Patients in Group 3 received 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation followed by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
TREATMENT
TRIPLE
Study Groups
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Paracetamol+Ibuprofen
Patients in Group 1 will receive a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation following by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
Paracetamol injection and Ibuprofen injection
Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
Paracetamol+normal saline
Patients in Group 2 will receive 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation following by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
Paracetamol injection and normal saline
Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Ibuprofen+normal saline
Patients in Group 3 will receive 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation following by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
Ibuprofen Injection and normal saline
Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Interventions
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Paracetamol injection and Ibuprofen injection
Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
Paracetamol injection and normal saline
Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Ibuprofen Injection and normal saline
Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patient with knee varus alignment 10-20°
Exclusion Criteria
* History of substance abuse or chronic pain.
* Patients are known to be hypersensitive to any of the components of IV ibuprofen or IV paracetamol.
* Patients currently on anticoagulation medications.
* Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board) and agree to abide by the study restrictions.
50 Years
75 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Andri Maruli Tua Lubis
Head of Research Division RSCM
Principal Investigators
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Andri MT Lubis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Aida R Tantri, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Ludwig AP Pontoh, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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Fatmawati General Hospital
Jakarta, DKI Jakarta, Indonesia
Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
Affas F, Nygards EB, Stiller CO, Wretenberg P, Olofsson C. Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block. Acta Orthop. 2011 Aug;82(4):441-7. doi: 10.3109/17453674.2011.581264. Epub 2011 May 11.
Barrington JW, Lovald ST, Ong KL, Watson HN, Emerson RH Jr. Postoperative Pain After Primary Total Knee Arthroplasty: Comparison of Local Injection Analgesic Cocktails and the Role of Demographic and Surgical Factors. J Arthroplasty. 2016 Sep;31(9 Suppl):288-92. doi: 10.1016/j.arth.2016.05.002. Epub 2016 May 12.
Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013 Mar;27(1):62-70. doi: 10.3109/15360288.2012.751956. Epub 2013 Jan 9.
Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.
Halawi MJ, Grant SA, Bolognesi MP. Multimodal Analgesia for Total Joint Arthroplasty. Orthopedics. 2015 Jul 1;38(7):e616-25. doi: 10.3928/01477447-20150701-61.
Oderda G. Challenges in the management of acute postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):6S-11S. doi: 10.1002/j.1875-9114.2012.01177.x.
Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.
Buvanendran A. Multimodal Analgesia for Perioperative Pain Management: ASA Refresh Courses Anesthesiol. 2012;40(1):1-6.
Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S-93S. doi: 10.1097/PRS.0000000000000671.
Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.
Dahl JB, Nielsen RV, Wetterslev J, Nikolajsen L, Hamunen K, Kontinen VK, Hansen MS, Kjer JJ, Mathiesen O; Scandinavian Postoperative Pain Alliance (ScaPAlli). Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. Acta Anaesthesiol Scand. 2014 Nov;58(10):1165-81. doi: 10.1111/aas.12382. Epub 2014 Aug 14.
Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
Thybo KH, Hagi-Pedersen D, Wetterslev J, Dahl JB, Schroder HM, Bulow HH, Bjorck JG, Mathiesen O. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.
McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.
Other Identifiers
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Pct-Ibf-FKUI
Identifier Type: -
Identifier Source: org_study_id