AnalgesiaPhase 2/3PctIbfFKUINCT04414995
Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty
A Phase 2/3 study testing Paracetamol injection and Ibuprofen injection, Paracetamol injection and normal saline and Ibuprofen Injection and normal saline in people with Analgesia, run by Universitas Indonesia at 2 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Paracetamol injection and Ibuprofen injection, Paracetamol injection and normal saline and Ibuprofen Injection and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesIndonesia
- Study dates
- 5 Jun 2020to 15 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient with 20 < BMI < 30 kg/m2
- Adult patient with knee varus alignment 10-20°
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Fatmawati General Hospital
Jakarta, DKI Jakarta, 12430
Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty
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.
Read the detailed 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
- Conditions
- Analgesia
- Being tested
- Paracetamol injection and Ibuprofen injection, Paracetamol injection and normal saline, Ibuprofen Injection and normal saline
- Keywords
- multi modal analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol injection and Ibuprofen injectionDrug
Also called Paracetamol and Ibuprofen
Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
Paracetamol injection and normal salineDrug
Also called Paracetamol injection
Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
Ibuprofen Injection and normal salineDrug
Also called Ibuprofen injection
Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol+Ibuprofen | Experimental | 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. Receives: Drug: Paracetamol injection and Ibuprofen injection |
| Paracetamol+normal saline | Experimental | 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. Receives: Drug: Paracetamol injection and normal saline |
| Ibuprofen+normal saline | Experimental | 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. Receives: Drug: Ibuprofen Injection and normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine requirement
morphine requirement in patient after total knee arthroplasty procedure
Measured: 24 hours
Secondary outcomes (3)
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")
Measured: 24 hours, 48 hours, 72 hours
range of motion knee in flexion and extension
range of motion knee in flexion and extension
Measured: 24 hours, 48 hours, 72 hours
2MWT after total knee arthroplasty procedure
amount of walking length in 2 minutes
Measured: 24 hours, 48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Jun 2020
- Primary completion30 Nov 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours. 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andri Maruli Tua Lubis, Universitas Indonesia
- Investigators
- Andri MT Lubis, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaAida R Tantri, MD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaLudwig AP Pontoh, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414995
- Sponsor's protocol ID
- Pct-Ibf-FKUI
- Acronym
- PctIbfFKUI
- Status last verified
- Dec 2020
- First submitted
- 31 May 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP)
Publications
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.
PubMed 22227789Affas 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.
PubMed 21561303Barrington 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.
PubMed 27318410Oderda 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.
PubMed 23302094Sharma 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.
PubMed 19277807Woolf 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.
PubMed 10846153Horlocker 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.
PubMed 16520363Halawi 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.
PubMed 26186325Oderda 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.
PubMed 22956493Barletta 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.
PubMed 22956490Buvanendran 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.
PubMed 25255012Derry 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.
PubMed 23794268Dahl 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.
PubMed 25124340Ong 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.
PubMed 20142348
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04414995
- Acronym / sponsor ID
- PctIbfFKUI / Pct-Ibf-FKUI
- Conditions
- Analgesia
- Keywords
- multi modal analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Patients in Group 1 received a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation followed by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours. 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.
| Arm | Type | Receives |
|---|---|---|
| Paracetamol+Ibuprofen | Experimental | Drug: Paracetamol injection and Ibuprofen injectionPatients 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+normal saline | Experimental | Drug: Paracetamol injection and normal salinePatients 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. |
| Ibuprofen+normal saline | Experimental | Drug: Ibuprofen Injection and normal salinePatients 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient with 20 < BMI < 30 kg/m2
- Adult patient with knee varus alignment 10-20°
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol injection and Ibuprofen injectionAlso: Paracetamol and IbuprofenUse of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty | Drug | Paracetamol+Ibuprofen |
| Paracetamol injection and normal salineAlso: Paracetamol injectionUse of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty | Drug | Paracetamol+normal saline |
| Ibuprofen Injection and normal salineAlso: Ibuprofen injectionUse of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty | Drug | Ibuprofen+normal saline |
Primary outcome
Total morphine requirement
Time frame: 24 hours
morphine requirement in patient after total knee arthroplasty procedure
3 secondary outcomes
Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase
Time frame: 24 hours, 48 hours, 72 hours
range of motion knee in flexion and extension
Time frame: 24 hours, 48 hours, 72 hours
2MWT after total knee arthroplasty procedure
Time frame: 24 hours, 48 hours, 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 22227789American 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.
- Background: PubMed 21561303Affas 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.
- Background: PubMed 27318410Barrington 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.
- Background: PubMed 23302094Oderda 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.
- Background: PubMed 19277807Sharma 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.
- Background: PubMed 10846153Woolf 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.
- Background: PubMed 16520363Horlocker 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.
- Background: PubMed 26186325Halawi 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.
- Background: PubMed 22956493Oderda 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.
- Background: PubMed 22956490Barletta 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.
- BackgroundBuvanendran A. Multimodal Analgesia for Perioperative Pain Management: ASA Refresh Courses Anesthesiol. 2012;40(1):1-6.
- Background: PubMed 25255012Rosero 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.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andri MT Lubis, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
Aida R Tantri, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
Ludwig AP Pontoh, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Paracetamol injection and Ibuprofen injection, Paracetamol injection and normal saline and Ibuprofen Injection and normal saline in people with Analgesia, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine requirement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414995, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.