Tendon InjuriesPhase 4Shoulder1NCT04110665
Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery
A Phase 4 study testing Tramadol, Nefopam 20 MG/ML and Morphine Sulfate in people with Tendon Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
This study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. In a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- Tramadol, Nefopam 20 MG/ML and Morphine Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 26 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- shoulder surgery
- under general anesthesia with an nterscalenic block
- written informed consent
- age > 18 years
Who cannot join
- age < 18years
- emergency surgery
- refusal
- drug or opioid abuses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery
This study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. In a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive nefopam or opioid in a sequential analysis that will be performed every 20 patients using the QoR 40 survey.
Read the detailed description
Multimodal analgesia using acetaminophen with non steroidal anti inflammatory is commonly used for pain relief after ambulatory surgery. Tramadol achieves pain relief when rescue analgesia is needed after this surgery, but induces side effects (nausea, vomiting, discomfort, sleep disorder...). Other drugs could be used to reduce the side effects of tramadol and improve postoperative experience : nefopam or opioid (immediate or delayed release medication). Using a survey that describes pain, comfort, emotion or physical status (QoR 40), the investigators analyse the impact of various multimodal strategies using tramadol or nefopam or opioid that is necessary to improve postoperative experience.
- Conditions
- Tendon Injuries
- Being tested
- Tramadol, Nefopam 20 MG/ML, Morphine Sulfate, Oxycodone 20mg
- Keywords
- shoulder, surgery, analgesia, opioid
- Medical subject headings
- Tendon Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Paracetamol, Ketoprofene
Tramadol 100 mg tablet
Nefopam 20 MG/MLDrug
Also called Paracetamol, Ketoprofene, Tramadol
120 mg for 24 hours
Morphine SulfateDrug
Also called Paracetamol, Ketoprofene
Tablet 10mg
Oxycodone 20mgDrug
Also called Paracetamol, Ketoprofene, Morphine Sulfate
release
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol+ ketoprofene and Tramadol | Active comparator | Paracetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours were systematically administered. Tramadol 100 mg per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). Receives: Drug: Tramadol |
| Paracetamol+ ketoprofene+ Nefopam and Tramadol | Active comparator | Paracetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours and Nefopam 120 mg intravenously were systematically administered. Tramadol 100 mg per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). Receives: Drug: Tramadol; Drug: Nefopam 20 MG/ML |
| Paracetamol+ ketoprofene and morphine | Active comparator | Paracetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours were systematically administered. Opioid immediate release (morphine 10 mg) per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). Receives: Drug: Morphine Sulfate |
| Paracetamol+ ketoprofene+Opioid delayed release and morphine | Active comparator | Paracetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours and 20 mg of opioid delayed release (Oxycodone) were systematically administered. Opioid immediate release (morphine 10 mg) per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). Receives: Drug: Morphine Sulfate; Drug: Oxycodone 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR) 40 survey
score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Sep 2017
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Evaluation of the treatment based on QoR40 survey every 20 patients
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- benjamin Garnaud, MD, Study director, CHU Nimes, Nimes University, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110665
- Sponsor's protocol ID
- Local/2017/PC-03
- Other IDs
- 2017-A01316-47
- Acronym
- Shoulder1
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garnaud B, Mares O, L'hermite J, Vialles N, Gricourt Y, Lannelongue A, Lefrant JY, Cuvillon P. Multimodal oral analgesia strategy after ambulatory arthroscopic shoulder surgery: case series using adaptive therapeutic approaches by sequential analysis. J Shoulder Elbow Surg. 2021 Feb;30(2):250-257. doi: 10.1016/j.jse.2020.08.040. Epub 2020 Sep 18.
PubMed 32950669
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT04110665
- Acronym / sponsor ID
- Shoulder1 / Local/2017/PC-03
- Conditions
- Tendon Injuries
- Keywords
- shoulder, surgery, analgesia, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 1 Oct 2019 (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.
This study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. In a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive nefopam or opioid in a sequential analysis that will be performed every 20 patients using the QoR 40 survey.
Detailed description
Multimodal analgesia using acetaminophen with non steroidal anti inflammatory is commonly used for pain relief after ambulatory surgery. Tramadol achieves pain relief when rescue analgesia is needed after this surgery, but induces side effects (nausea, vomiting, discomfort, sleep disorder...). Other drugs could be used to reduce the side effects of tramadol and improve postoperative experience : nefopam or opioid (immediate or delayed release medication). Using a survey that describes pain, comfort, emotion or physical status (QoR 40), the investigators analyse the impact of various multimodal strategies using tramadol or nefopam or opioid that is necessary to improve postoperative experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Evaluation of the treatment based on QoR40 survey every 20 patients
| Arm | Type | Receives |
|---|---|---|
| Paracetamol+ ketoprofene and Tramadol | Active comparator | Drug: TramadolParacetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours were systematically administered. Tramadol 100 mg per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). |
| Paracetamol+ ketoprofene+ Nefopam and Tramadol | Active comparator | Drug: Tramadol, Drug: Nefopam 20 MG/MLParacetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours and Nefopam 120 mg intravenously were systematically administered. Tramadol 100 mg per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). |
| Paracetamol+ ketoprofene and morphine | Active comparator | Drug: Morphine SulfateParacetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours were systematically administered. Opioid immediate release (morphine 10 mg) per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). |
| Paracetamol+ ketoprofene+Opioid delayed release and morphine | Active comparator | Drug: Morphine Sulfate, Drug: Oxycodone 20mgParacetamol per os 1g every 6 hours and ketoprofene 100 mg per os every 12 hours and 20 mg of opioid delayed release (Oxycodone) were systematically administered. Opioid immediate release (morphine 10 mg) per os every 6 hours was added when pain was > 3/10 on a numeric ranking scale (0 no pain, 10 worst pain). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- shoulder surgery
- under general anesthesia with an nterscalenic block
- written informed consent
- age > 18 years
Key exclusion criteria (4 listed)
- age < 18years
- emergency surgery
- refusal
- drug or opioid abuses
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 |
|---|---|---|
| TramadolAlso: Paracetamol, KetoprofeneTramadol 100 mg tablet | Drug | Paracetamol+ ketoprofene and Tramadol, Paracetamol+ ketoprofene+ Nefopam and Tramadol |
| Nefopam 20 MG/MLAlso: Paracetamol, Ketoprofene, Tramadol120 mg for 24 hours | Drug | Paracetamol+ ketoprofene+ Nefopam and Tramadol |
| Morphine SulfateAlso: Paracetamol, KetoprofeneTablet 10mg | Drug | Paracetamol+ ketoprofene and morphine, Paracetamol+ ketoprofene+Opioid delayed release and morphine |
| Oxycodone 20mgAlso: Paracetamol, Ketoprofene, Morphine Sulfaterelease | Drug | Paracetamol+ ketoprofene+Opioid delayed release and morphine |
Primary outcome
Quality of Recovery (QoR) 40 survey
Time frame: Day 2
score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 32950669Garnaud B, Mares O, L'hermite J, Vialles N, Gricourt Y, Lannelongue A, Lefrant JY, Cuvillon P. Multimodal oral analgesia strategy after ambulatory arthroscopic shoulder surgery: case series using adaptive therapeutic approaches by sequential analysis. J Shoulder Elbow Surg. 2021 Feb;30(2):250-257. doi: 10.1016/j.jse.2020.08.040. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No
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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.
benjamin Garnaud, MD study director
CHU Nimes, Nimes University, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol, Nefopam 20 MG/ML and Morphine Sulfate in people with Tendon Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 Dec 2025. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Recovery (QoR) 40 survey (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110665, which also lists 1 linked publication.
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 16 Dec 2025.