Tapentadol vs Tramadol in Total Knee Arthroplasty

Last updated: May 10, 2024
Sponsor: University of Thessaly
Overall Status: Active - Recruiting

Phase

4

Condition

Pain

Chronic Pain

Treatment

Tramadol

Tapentadol

Clinical Study ID

NCT06269770
Tapentadol
  • Ages 18-80
  • All Genders

Study Summary

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients for elective TKR

  • ASA PS I - III

Exclusion

Exclusion Criteria:

  • Patient refusal

  • Cognitive disfunction

  • Severe psychiatric disease

  • Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptakeinhibitors

  • 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

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Tramadol
Phase: 4
Study Start date:
May 01, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • University Hospital Of Larissa

    Larissa, Thessaly 41110
    Greece

    Active - Recruiting

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