Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty

Analgesia Clinical Trial

— PctIbfFKUI  

Official title:

Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414995
• Other study ID #: Pct-Ibf-FKUI
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 5, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adequate pain management has an important role in supporting early ambulation after the Total Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to reduce total morphine consumption after TKA.

Description:

The research will compare the effect of paracetamol injection and ibuprofen injection when given alone or in combination to reduce morphine requirement in a patient after total knee arthroplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult patient with 20 < BMI < 30 kg/m2
• Adult patient with knee varus alignment 10-20°

Exclusion Criteria:

• Impaired cardiac, liver, and/or renal function.
• 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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Indonesia	Fatmawati General Hospital	Jakarta	DKI Jakarta
Indonesia	Cipto Mangunkusumo National General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

Affas F, Nygårds 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Buvanendran A. Multimodal Analgesia for Perioperative Pain Management: ASA Refresh Courses Anesthesiol. 2012;40(1):1-6.

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. Review. — View Citation

Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;(6):CD010210. doi: 10.1002/14651858.CD010210.pub2. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Thybo KH, Hägi-Pedersen D, Wetterslev J, Dahl JB, Schrøder HM, Bülow HH, Bjørck 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. — View Citation

Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine requirement	morphine requirement in patient after total knee arthroplasty procedure	24 hours
Secondary	Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase	amount of pain measure by numerical rating scale. Patients rate their pain from 0 to 10, Zero represents "no pain," whereas 10 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain")	24 hours, 48 hours, 72 hours
Secondary	range of motion knee in flexion and extension	range of motion knee in flexion and extension	24 hours, 48 hours, 72 hours
Secondary	2MWT after total knee arthroplasty procedure	amount of walking length in 2 minutes	24 hours, 48 hours, 72 hours