NCT06269770

Tapentadol vs Tramadol in Total Knee Arthroplasty

Multimodal Analgesia in TKA. The Role of Tapentadol

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Thessaly · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Tapentadol	Add tapentadol, for effective pain management in a multimodal setting during TKR.
DRUG	Tramadol	Add tramadol, for effective pain management in a multimodal setting during TKR.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-02-21
• Last updated: 2024-05-14

Locations

1 site across 1 country: Greece