Arthroscopic Rotator Cuff Repair (ARCR), Chronic Pain, Postoperative Pain
Conditions
Keywords
Arthroscopic rotator cuff repair, postoperrative pain, chronic pain, tramadol, tapentadol
Brief summary
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery.
Detailed description
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.
Interventions
DRUGTramadol
Add tapentadol, for effective pain management in a multimodal setting during ARCR
DRUGTapentadol
Add tramadol, for effective pain management in a multimodal setting during ARCR
Sponsors
University of Thessaly
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 6 hours after surgery | Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 3 weeks after surgery | Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain) |
| Neuropathic pain | 6 months after surgery | PainDETECT (0-35) |
| Quality of recovery | preoperatively | Quality of Recovery-15 ( QoR15) |
| Patient Satisfaction | 1st postoperative day | 5-point Likert scale (0-5) \[5 representing higher satisfaction\] |
| Function | 6 weeks after surgery | ROWE Score |
| Quality of sleep | 1st postoperative day | Athens Insomnia Scale |
| Depression | preoperatively | Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\] |
| Health Status | preoperatively | 5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\] |
| Surgeon Satisfaction | 1st postoperative day | 5-point Likert scale (0-5) \[5 representing higher satisfaction\] |
| Joint awareness | 6 weeks after surgery | Forgotten Joint Score (FJS) |
| Nausia and vomiting | 1st postoperative day | Apfel Score |
| Patient comorbidities | properatively | Charlson scale |
Countries
Greece
Contacts
STUDY_CHAIREleni Arnaoutolglou, MD, PhD
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Principal Investigator
PRINCIPAL_INVESTIGATORMetaxia Bareka, MD, PhD
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
Outcome results
None listed