Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery

Conditions
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Tendon Injuries

Intervention / Treatment
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* Drug: Tramadol
* Drug: Nefopam 20 MG/ML
* Drug: Morphine Sulfate
* Drug: Oxycodone 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: shoulder surgery under general anesthesia with an nterscalenic block written informed consent age > 18 years Exclusion Criteria: age < 18years emergency surgery refusal drug or opioid abuses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Evaluation of the treatment based on QoR40 survey every 20 patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol+ ketoprofene and Tramadol<br>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). | Drug: Tramadol<br>* Tramadol 100 mg tablet<br>* Other names: Ketoprofene;|
| Active Comparator: Paracetamol+ ketoprofene+ Nefopam and Tramadol<br>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). | Drug: Tramadol<br>* Tramadol 100 mg tablet<br>* Other names: Ketoprofene;Drug: Nefopam 20 MG/ML<br>* 120 mg for 24 hours<br>* Other names: Tramadol;|
| Active Comparator: Paracetamol+ ketoprofene and morphine<br>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). | Drug: Morphine Sulfate<br>* Tablet 10mg<br>* Other names: Ketoprofene;|
| Active Comparator: Paracetamol+ ketoprofene+Opioid delayed release and morphine<br>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). | Drug: Morphine Sulfate<br>* Tablet 10mg<br>* Other names: Ketoprofene;Drug: Oxycodone 20mg<br>* release<br>* Other names: Morphine Sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery (QoR) 40 survey | score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question) | Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, surgery, analgesia, opioid