Total Knee ReplacementPhase 4NCT06269770
Tapentadol vs Tramadol in Total Knee Arthroplasty
A Phase 4 study testing Tapentadol and Tramadol in people with Total Knee Replacement and Post-operative Pain, run by University of Thessaly at 1 site in Greece.
Trial summary
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement, Post-operative Pain, Chronic Pain
- What is being tested?
- Tapentadol and Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2023to 1 Jun 2025
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for elective TKR
- ASA PS I - III
Who cannot join
- Patient refusal
- Cognitive disfunction
- Severe psychiatric disease
- Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
- Not speaking Greek
- Known allergy to the study drugs
Show all 12Show fewer
- Contraindications for any of the study drugs
- Chronic renal failure (GFR < 50 ml/h)
- Liver failure
- Known regular use or misuse of opioids
- Pregnant women
- Patients undergoing general anesthesia
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital Of Larissa
Larissa, Thessaly, 41110
About this study
Official title: Multimodal Analgesia in TKA. The Role of Tapentadol
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).
Read the detailed description
As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.
Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.
A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.
In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.
To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.
- Conditions
- Total Knee Replacement, Post-operative Pain, Chronic Pain
- Being tested
- Tapentadol, Tramadol
- Keywords
- total knee replacement, post-operative pain, tramadol, tapentadol
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Add tapentadol, for effective pain management in a multimodal setting during TKR.
TramadolDrug
Add tramadol, for effective pain management in a multimodal setting during TKR.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain. Receives: Drug: Tramadol |
| Tapentadol | Active comparator | Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. Receives: Drug: Tapentadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 hours after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 12 hours after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 1st postoperative day
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 2nd postoperative day
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 3rd postoperative day
Secondary outcomes (12)
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 3 weeks after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 weeks after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 months after surgery
Neuropathic pain
PainDETECT (0-35)
Measured: 6 months after surgery
Quality of life postoperatively
Patient Quality 15 (0-150)
Measured: 6 months after surgery
Patient Satisfaction
5-point Likert scale (0-5) [5 representing higher satisfaction]
Measured: 5 days after surgery at Discharge
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]
Measured: 5 days after surgery at Discharge
Function
Oxford Knee Score (OKS) (0-48)
Measured: 6 weeks after surgery
Outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)
Measured: 6 weeks after surgery
Arthritis impact
ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale
Measured: 6 weeks after surgery
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) [The higher the score, the worse the health status]
Measured: 6 weeks after surgery
Pain severity
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) [The higher the score the higher the disability due to osteoarthritis]
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutolglou, MD, PhD, Study chair, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of ThessalyMetaxia Bareka, MD, PhD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269770
- Sponsor's protocol ID
- Tapentadol
- Status last verified
- May 2024
- First submitted
- 3 Feb 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.
PubMed 24641894Roulet L, Rollason V, Desmeules J, Piguet V. Tapentadol Versus Tramadol: A Narrative and Comparative Review of Their Pharmacological, Efficacy and Safety Profiles in Adult Patients. Drugs. 2021 Jul;81(11):1257-1272. doi: 10.1007/s40265-021-01515-z. Epub 2021 Jul 1.
PubMed 34196947Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.
PubMed 32773594
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia in TKA. The Role of Tapentadol
- ClinicalTrials.gov ID
- NCT06269770
- Acronym / sponsor ID
- Tapentadol
- Conditions
- Total Knee Replacement, Post-operative Pain, Chronic Pain
- Keywords
- total knee replacement, post-operative pain, tramadol, tapentadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Feb 2024 (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.
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).
Detailed description
As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.
Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.
A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.
In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.
To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: TramadolTramadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
| Tapentadol | Active comparator | Drug: TapentadolTapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients for elective TKR
- ASA PS I - III
Key exclusion criteria (12 listed)
- Patient refusal
- Cognitive disfunction
- Severe psychiatric disease
- Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
- Not speaking Greek
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 |
|---|---|---|
| TapentadolAdd tapentadol, for effective pain management in a multimodal setting during TKR. | Drug | Tapentadol |
| TramadolAdd tramadol, for effective pain management in a multimodal setting during TKR. | Drug | Tramadol |
Primary outcome
Post-operative pain
Time frame: 6 hours after surgery
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 12 hours after surgery
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 1st postoperative day
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 2nd postoperative day
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 3rd postoperative day
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
12 secondary outcomes
Post-operative pain
Time frame: 3 weeks after surgery
Post-operative pain
Time frame: 6 weeks after surgery
Post-operative pain
Time frame: 6 months after surgery
Neuropathic pain
Time frame: 6 months after surgery
Quality of life postoperatively
Time frame: 6 months after surgery
Patient Satisfaction
Time frame: 5 days after surgery at Discharge
Depression
Time frame: 5 days after surgery at Discharge
Function
Time frame: 6 weeks after surgery
Outcome
Time frame: 6 weeks after surgery
Arthritis impact
Time frame: 6 weeks after surgery
Health Status
Time frame: 6 weeks after surgery
Pain severity
Time frame: 6 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 24641894Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.
- Background: PubMed 34196947Roulet L, Rollason V, Desmeules J, Piguet V. Tapentadol Versus Tramadol: A Narrative and Comparative Review of Their Pharmacological, Efficacy and Safety Profiles in Adult Patients. Drugs. 2021 Jul;81(11):1257-1272. doi: 10.1007/s40265-021-01515-z. Epub 2021 Jul 1.
- Background: PubMed 32773594Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.
- Individual participant dataSharing planned: No
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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.
Eleni Arnaoutolglou, MD, PhD study chair
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
Metaxia Bareka, MD, PhD principal investigator
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tapentadol and Tramadol in people with Total Knee Replacement and Post-operative Pain, run by University of Thessaly at 1 site in Greece.
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 12 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: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, MD, PhD (00302413502952, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 6 hours after surgery). The study lists 5 primary outcomes in all. 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 NCT06269770, which also lists 3 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 14 May 2024.