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.
Study Type
OBSERVATIONAL
Enrollment
64
Add tapentadol, for effective pain management in a multimodal setting during ARCR
Add tramadol, for effective pain management in a multimodal setting during ARCR
Larissa University Hospital
Larissa, Thessaly, Greece
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 hours after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 12 hours after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 1st postoperative day
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 2nd postoperative day
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 3rd postoperative day
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 3 weeks after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 weeks after surgery
Post-operative pain
Numerical Rating Scale (NRS) 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 3 months after surgery
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Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 months after surgery
Neuropathic pain
PainDETECT (0-35)
Time frame: 6 months after surgery
Quality of recovery
Quality of Recovery-15 ( QoR15)
Time frame: preoperatively
Patient Satisfaction
5-point Likert scale (0-5) \[5 representing higher satisfaction\]
Time frame: 1st postoperative day
Function
ROWE Score
Time frame: 6 weeks after surgery
Function
ROWE Score
Time frame: 3 months after surgery
Function
ROWE Score
Time frame: 6 months after surgery
Function
The Constant-Murley Score
Time frame: 6 weeks after surgery
Function
The Constant-Murley Score
Time frame: 3 months after surgery
Function
The Constant-Murley Score
Time frame: 6 months after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand)
Time frame: 6 weeks after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand)
Time frame: 3 months after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand)
Time frame: 6 months after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score
Time frame: 6 weeks after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score
Time frame: 3 months after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score
Time frame: 6 months after surgery
Quality of sleep
Athens Insomnia Scale
Time frame: 1st postoperative day
Quality of sleep
Athens Insomnia Scale
Time frame: 2nd postoperative day
Quality of sleep
Athens Insomnia Scale
Time frame: 3rd postoperative day
Quality of sleep
Athens Insomnia Scale
Time frame: 3 weeks after surgery
Quality of sleep
Athens Insomnia Scale
Time frame: 6 weeks after surgery
Quality of sleep
Athens Insomnia Scale
Time frame: 3 months after surgery
Quality of sleep
Athens Insomnia Scale
Time frame: 6 months after surgery
Quality of recovery
Quality of Recovery-15 ( QoR15)
Time frame: 24 hours after surgery
Neuropathic pain
PainDETECT (0-35)
Time frame: 3 months after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Time frame: preoperatively
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Time frame: 6 weeks after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Time frame: 3 months after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Time frame: 6 months after surgery
Neuropathic pain
PainDETECT (0-35)
Time frame: preoperatively
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Time frame: preoperatively
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Time frame: 6 weeks after surgery
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Time frame: 3 months after surgery
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Time frame: 6 months after surgery
Quality of sleep
Athens Insomnia Scale
Time frame: preoperatively
Surgeon Satisfaction
5-point Likert scale (0-5) \[5 representing higher satisfaction\]
Time frame: 1st postoperative day
Joint awareness
Forgotten Joint Score (FJS)
Time frame: 6 weeks after surgery
Joint awareness
Forgotten Joint Score (FJS)
Time frame: 3 months after surgery
Joint awareness
Forgotten Joint Score (FJS)
Time frame: 6 months after surgery
Joint awareness
Forgotten Joint Score (FJS)
Time frame: preoperatively
Function
The Constant-Murley Score
Time frame: preoperatively
Function
ROWE Score
Time frame: preoperatively
Function
DASH score (Disabilities of the Arm, Shoulder and Hand)
Time frame: preoperatively
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score
Time frame: preoperatively
Nausia and vomiting
Apfel Score
Time frame: 1st postoperative day
Nausia and vomiting
Apfel Score
Time frame: 2nd postoperative day
Nausia and vomiting
Apfel Score
Time frame: 3rd postoperative day
Patient comorbidities
Charlson scale
Time frame: properatively