Comparing tapentadol and tramadol for pain relief after knee surgery
Multimodal Analgesia in TKA. The Role of Tapentadol
This study is testing whether tapentadol or tramadol works better for pain relief in people recovering from knee surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Larissa, Thessaly) |
| Trial ID | NCT06269770 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of tapentadol and tramadol as part of a multimodal analgesia approach for patients undergoing total knee replacement (TKR). It aims to address the challenges of postoperative pain management, which can lead to longer hospital stays and increased risk of chronic pain. The study utilizes a combination of spinal anesthesia and various analgesics, including dexmedetomidine and NSAIDs, to optimize pain relief while minimizing opioid use. By evaluating these two medications, the study seeks to determine which provides better outcomes for patients recovering from TKR.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective total knee replacement who are classified as ASA PS I-III.
Not a fit: Patients who may not benefit from this study include those with cognitive dysfunction, severe psychiatric disease, or contraindications to the study drugs.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing total knee replacement, potentially reducing the incidence of chronic pain.
How similar studies have performed: Other studies have shown promising results in using multimodal analgesia for postoperative pain management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients for elective TKR * ASA PS I - III 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
Where this trial is running
Larissa, Thessaly
- University Hospital Of Larissa — Larissa, Thessaly, Greece (Recruiting)
Study contacts
- Principal investigator: Metaxia Bareka, MD, PhD — Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
- Study coordinator: Eleni Arnaoutoglou, MD, PhD
- Email: earnaout@gmail.com
- Phone: 00302413502952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.