Arthroscopic Rotator Cuff Repair (ARCR)NCT07779473
Tapentadol vs Tramadol in Arthroscopic Rotator Cuff Repair
An observational study of Arthroscopic Rotator Cuff Repair (ARCR) and Postoperative Pain, run by University of Thessaly at 1 site in Greece.
Trial summary
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroscopic Rotator Cuff Repair (ARCR), Postoperative Pain, Chronic Pain
- What is being tested?
- Tramadol and Tapentadol
- How many people
- 64 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2026to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo arthroscopic rotator cuff surgery
Who may be able to join
- Patients for elective ARCR
- ASA PS I - III
- Age 18-80 (adults)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Tramadol vs Tapentadol as Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery.
Read the 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.
- Being tested
- Tramadol, Tapentadol
- Keywords
- Arthroscopic rotator cuff repair, postoperrative pain, chronic pain, tramadol, tapentadol
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Add tapentadol, for effective pain management in a multimodal setting during ARCR
TapentadolDrug
Add tramadol, for effective pain management in a multimodal setting during ARCR
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain. Receives: Drug: Tramadol | |
| Tapentadol | Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. Receives: Drug: Tapentadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 hours after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 12 hours after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 1st postoperative day
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 2nd postoperative day
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 3rd postoperative day
Secondary outcomes (51)
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 3 weeks after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 weeks after surgery
Post-operative pain
Numerical Rating Scale (NRS) 0 to 10 (0=no pain, 10=the worst pain)
Measured: 3 months after surgery
Post-operative pain
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Measured: 6 months after surgery
Neuropathic pain
PainDETECT(not an abbreviation) (0-35 scale with 0-12 being negative result for neuropathic pain 13-18 ambiguous result and 19-35 positive for neuropathic pain)
Measured: 6 months after surgery
Quality of recovery
Quality of Recovery-15 ( QoR15) ( scale 0-10 with 0 being poor outcome and 10 being excellent outcome)
Measured: preoperatively
Patient Satisfaction
5-point Likert scale (not an abbreviation) (0-5) [5 representing higher satisfaction]
Measured: 1st postoperative day
Function
ROWE Score(not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 weeks after surgery
Function
ROWE Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 3 months after surgery
Function
ROWE Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 months after surgery
Function
The Constant-Murley Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 weeks after surgery
Function
The Constant-Murley Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 3 months after surgery
Function
The Constant-Murley Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 months after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand)(scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 weeks after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 3 months after surgery
Function
DASH score (Disabilities of the Arm, Shoulder and Hand) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: 6 months after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score (scale 0-100 with 0 being poor outcome 100 being excellent outcome and is split evenly into two 0-50 subscores for pain and function)
Measured: 6 weeks after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score (scale 0-100 with 0 being poor outcome 100 being excellent outcome and is split evenly into two 0-50 subscores for pain and function)
Measured: 3 months after surgery
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score (scale 0-100 with 0 being poor outcome 100 being excellent outcome and is split evenly into two 0-50 subscores for pain and function)
Measured: 6 months after surgery
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 1st postoperative day
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 2nd postoperative day
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 3rd postoperative day
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 3 weeks after surgery
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 6 weeks after surgery
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 3 months after surgery
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 6 months after surgery
Quality of recovery
Quality of Recovery-15 ( QoR15) (scale 0-10 with 0 being poor outcome and 10 being excellent outcome)
Measured: 24 hours after surgery
Neuropathic pain
PainDETECT (0-35) (not an abbreviation) (0-35 scale with 0-12 being negative result for neuropathic pain 13-18 ambiguous result and 19-35 positive for neuropathic pain)
Measured: 3 months after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]
Measured: preoperatively
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]
Measured: 6 weeks after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]
Measured: 3 months after surgery
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression]
Measured: 6 months after surgery
Neuropathic pain
PainDETECT (0-35) (not an abbreviation) (0-35 scale with 0-12 being negative result for neuropathic pain 13-18 ambiguous result and 19-35 positive for neuropathic pain)
Measured: 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] (not an abbreviation)
Measured: 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] (not an abbreviation)
Measured: 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] (not an abbreviation)
Measured: 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] (not an abbreviation)
Measured: 6 months after surgery
Quality of sleep
Athens Insomnia Scale (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: preoperatively
Surgeon Satisfaction
5-point Likert scale (0-5) [5 representing higher satisfaction] (scale 0-24 with 0 being excellent outcome and 24 being poor outcome)
Measured: 1st postoperative day
Joint awareness
Forgotten Joint Score (FJS) (scale 0-100 with 0 being poor outcome and 100 being excellent outcome)
Measured: 6 weeks after surgery
Joint awareness
Forgotten Joint Score (FJS) (scale 0-100 with 0 being poor outcome and 100 being excellent outcome)
Measured: 3 months after surgery
Joint awareness
Forgotten Joint Score (FJS) (scale 0-100 with 0 being poor outcome and 100 being excellent outcome)
Measured: 6 months after surgery
Joint awareness
Forgotten Joint Score (FJS) (scale 0-100 with 0 being poor outcome and 100 being excellent outcome)
Measured: preoperatively
Function
The Constant-Murley Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: preoperatively
Function
ROWE Score (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: preoperatively
Function
DASH score (Disabilities of the Arm, Shoulder and Hand) (not an abbreviation) (scale 0-100 with 0 being poor outcome 100 being excellent outcome)
Measured: preoperatively
Function
ASES (American Shoulder and Elbow Surgeons) Shoulder Score (scale 0-100 with 0 being poor outcome 100 being excellent outcome and is split evenly into two 0-50 subscores for pain and function)
Measured: preoperatively
Nausia and vomiting
Apfel Score (not an abbreviation) (scale 0-4 with 0 being excellent outcome 4 being poor outcome)
Measured: 1st postoperative day
Nausia and vomiting
Apfel Score (not an abbreviation) (scale 0-4 with 0 being excellent outcome 4 being poor outcome)
Measured: 2nd postoperative day
Nausia and vomiting
Apfel Score (not an abbreviation) (scale 0-4 with 0 being excellent outcome 4 being poor outcome)
Measured: 3rd postoperative day
Patient comorbidities
Charlson scale (not an abbreviation) (scale that 0 means excellent outcome and more than 5 means poor outcome, there is no absolute scale number)
Measured: properatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Rotator Cuff Repair (ARCR)Studies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutolglou, MD, PhD, Study chair, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Principal InvestigatorMetaxia Bareka, MD, PhD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779473
- Sponsor's protocol ID
- 17/3/10-02-26
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tramadol vs Tapentadol as Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery
- ClinicalTrials.gov ID
- NCT07779473
- Acronym / sponsor ID
- 17/3/10-02-26
- Keywords
- Arthroscopic rotator cuff repair, postoperrative pain, chronic pain, tramadol, tapentadol
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | – | Drug: TramadolTramadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
| Tapentadol | – | Drug: TapentadolTapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo arthroscopic rotator cuff surgery
Key inclusion criteria (3 listed)
- Patients for elective ARCR
- ASA PS I - III
- Age 18-80 (adults)
Key exclusion criteria (12 listed)
- Patient refusal
- Cognitive disfunction
- Severe psychiatric disease
- Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
- Not speaking Greek
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolAdd tapentadol, for effective pain management in a multimodal setting during ARCR | Drug | Tramadol |
| TapentadolAdd tramadol, for effective pain management in a multimodal setting during ARCR | Drug | Tapentadol |
Primary outcome
Post-operative pain
Time frame: 6 hours after surgery
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 12 hours after surgery
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 1st postoperative day
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 2nd postoperative day
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Post-operative pain
Time frame: 3rd postoperative day
Numerical Rating Scale (NRS) score measures 0 to 10 (0=no pain, 10=the worst pain)
51 secondary outcomes
Post-operative pain
Time frame: 3 weeks after surgery
Post-operative pain
Time frame: 6 weeks after surgery
Post-operative pain
Time frame: 3 months after surgery
Post-operative pain
Time frame: 6 months after surgery
Neuropathic pain
Time frame: 6 months after surgery
Quality of recovery
Time frame: preoperatively
Patient Satisfaction
Time frame: 1st postoperative day
Function
Time frame: 6 weeks after surgery
Function
Time frame: 3 months after surgery
Function
Time frame: 6 months after surgery
Function
Time frame: 6 weeks after surgery
Function
Time frame: 3 months after surgery
Function
Time frame: 6 months after surgery
Function
Time frame: 6 weeks after surgery
Function
Time frame: 3 months after surgery
Function
Time frame: 6 months after surgery
Function
Time frame: 6 weeks after surgery
Function
Time frame: 3 months after surgery
Function
Time frame: 6 months after surgery
Quality of sleep
Time frame: 1st postoperative day
Quality of sleep
Time frame: 2nd postoperative day
Quality of sleep
Time frame: 3rd postoperative day
Quality of sleep
Time frame: 3 weeks after surgery
Quality of sleep
Time frame: 6 weeks after surgery
Quality of sleep
Time frame: 3 months after surgery
Quality of sleep
Time frame: 6 months after surgery
Quality of recovery
Time frame: 24 hours after surgery
Neuropathic pain
Time frame: 3 months after surgery
Depression
Time frame: preoperatively
Depression
Time frame: 6 weeks after surgery
Depression
Time frame: 3 months after surgery
Depression
Time frame: 6 months after surgery
Neuropathic pain
Time frame: preoperatively
Health Status
Time frame: preoperatively
Health Status
Time frame: 6 weeks after surgery
Health Status
Time frame: 3 months after surgery
Health Status
Time frame: 6 months after surgery
Quality of sleep
Time frame: preoperatively
Surgeon Satisfaction
Time frame: 1st postoperative day
Joint awareness
Time frame: 6 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Arthroscopic Rotator Cuff Repair (ARCR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Arnaoutolglou, MD, PhD study chair
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Principal Investigator
Metaxia Bareka, MD, PhD principal investigator
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopic Rotator Cuff Repair (ARCR) and Postoperative Pain, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 6 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.