Comparison of Tramadol vs Tapentadol as Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery
| Registry | NCT07779473 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 64 (Estimated) |
| Sponsor | University of Thessaly (Other) |
| Conditions | Arthroscopic Rotator Cuff Repair (ARCR), Postoperative Pain, Chronic Pain |
| Interventions | Tramadol, Tapentadol (Drug) |
| Dates | start 2026-07-01, primary completion 2029-07-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-08-21, last updated 2026-10-21 |
| Locations | 1 site in Greece |
Related Papers Related Patents Related Grants Related Experts
All trials for Arthroscopic Rotator Cuff Repair (ARCR) All trials for Postoperative Pain All trials of Tramadol All trials of Tapentadol
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery.
Arthroscopic rotator cuff repair (ARCR) is considered the treatment of choice for rotator cuff tears. Despite its minimally invasive nature, the procedure is associated with significant acute postoperative pain and, in a proportion of patients, with the development of chronic postoperative pain and stiffness, which may adversely affect rehabilitation, functional outcomes, and quality of life.
Contemporary postoperative pain management is based on multimodal analgesic protocols aimed at achieving adequate pain control while reducing opioid use and opioid-related adverse effects. Tramadol and tapentadol are centrally acting opioids with atypical mechanisms of action that are commonly used in clinical practice as part of multimodal analgesia. However, available data regarding their comparative effectiveness and safety in patients undergoing ARCR remain limited.
The aim of the present study is to compare the effectiveness of tapentadol versus tramadol in the management of postoperative pain in patients undergoing arthroscopic rotator cuff repair at the University General Hospital of Larissa.
The study will include patients aged 18-80 years, classified as ASA Physical Status I-III, who meet the predefined inclusion and exclusion criteria. Participants will be randomized into two groups and will receive, within a standardized multimodal analgesic protocol, either tapentadol or tramadol. All patients will undergo identical anesthetic and surgical management in accordance with established departmental clinical practice.
The primary outcome measure is pain intensity at rest and during movement, assessed using validated pain scales (VAS/NRS) at 6, 12, and 24 postoperative hours, as well as on postoperative days 1, 2, and 3. Secondary outcome measures include the occurrence of adverse effects, sleep quality, patient and surgeon satisfaction, and measures of functional outcome, quality of recovery, and quality of life assessed at 3 and up to 6 months postoperatively. The presence of neuropathic pain will also be assessed preoperatively and at 3 and 6 months postoperatively using the PainDETECT questionnaire, while depressive symptoms will be evaluated preoperatively and at 6 weeks, 3 months, and 6 months postoperatively using the Patient Health Questionnaire-9 (PHQ-9).
Participation will be entirely voluntary following the provision of written informed consent. Participant anonymity and personal data protection will be ensured in accordance with applicable national and European legislation (GDPR). This study is expected to contribute to the optimization of postoperative analgesic protocols following ARCR and to the improvement of the quality of patient care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tramadol | Drug: Tramadol | Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain. | |
| Tapentadol | Drug: Tapentadol | Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * Patients for elective ARCR * ASA PS I - III * Age 18-80 (adults) 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
| Facility | City | Country | Status |
|---|---|---|---|
| Larissa University Hospital | Larissa, Thessaly | Greece |