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RecruitingNCT06269770Updated May 14, 2024

Tapentadol vs Tramadol in Total Knee Arthroplasty

A Phase 4 interventional study of Tapentadol and Tramadol in Total Knee Replacement, Post-operative Pain and Chronic Pain, sponsored by University of Thessaly. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by University of Thessaly · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled May 2023, registered Feb 2024).
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Total Knee Replacement
  • Post-operative Pain
  • Chronic Pain

Keywords

  • total knee replacement
  • post-operative pain
  • tramadol
  • tapentadol
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 96 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients for elective TKR
  • ASA PS I - III

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Active comparator
    Tramadol

    Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.

    Drug: Tramadol

  • Active comparator
    Tapentadol

    Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.

    Drug: Tapentadol

Interventions

  • DrugTapentadol

    Add tapentadol, for effective pain management in a multimodal setting during TKR.

  • DrugTramadol

    Add tramadol, for effective pain management in a multimodal setting during TKR.

06

What researchers measure

Primary outcomes

  1. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 6 hours after surgery

  2. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 12 hours after surgery

  3. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 1st postoperative day

  4. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 2nd postoperative day

  5. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 3rd postoperative day

Secondary outcomes

  1. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 3 weeks after surgery

  2. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 6 weeks after surgery

  3. Post-operative pain

    Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)

    Time frame: 6 months after surgery

  4. Neuropathic pain

    PainDETECT (0-35)

    Time frame: 6 months after surgery

  5. Quality of life postoperatively

    Patient Quality 15 (0-150)

    Time frame: 6 months after surgery

  6. Patient Satisfaction

    5-point Likert scale (0-5) \[5 representing higher satisfaction\]

    Time frame: 5 days after surgery at Discharge

  7. Depression

    Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]

    Time frame: 5 days after surgery at Discharge

  8. Function

    Oxford Knee Score (OKS) (0-48)

    Time frame: 6 weeks after surgery

  9. Outcome

    Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)

    Time frame: 6 weeks after surgery

  10. Arthritis impact

    ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale

    Time frame: 6 weeks after surgery

  11. Health Status

    5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]

    Time frame: 6 weeks after surgery

  12. Pain severity

    Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) \[The higher the score the higher the disability due to osteoarthritis\]

    Time frame: 6 weeks after surgery

07

Study locations

1 of 1 sites recruiting
  • University Hospital Of Larissa
    Larissa, Thessaly 41110, Greece
    Recruiting
08

References and documents

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 24641894 ↗
  • Roulet 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 34196947 ↗
  • Rian 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06269770
Lead sponsor
University of Thessaly
Responsible party
Elena Arnaoutoglou (Professor in Anesthesiology, University of Thessaly) — Principal investigator
First posted
Feb 21, 2024
Start date
May 1, 2023
Primary completion
May 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
May 14, 2024

Study contacts

Eleni Arnaoutoglou, MD, PhD
Contact
earnaout@gmail.com
00302413502952
Metaxia Bareka, MD, PhD
Contact
barekametaxia@hotmail.com
+306947845083
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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