Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery
- Conditions
- Tendon Injuries
- Interventions
- Registration Number
- NCT04110665
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- shoulder surgery
- under general anesthesia with an nterscalenic block
- written informed consent
- age > 18 years
- age < 18years
- emergency surgery
- refusal
- drug or opioid abuses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Paracetamol+ ketoprofene+ Nefopam and Tramadol Nefopam 20 MG/ML 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). Paracetamol+ ketoprofene+Opioid delayed release and morphine Oxycodone 20mg 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). Paracetamol+ ketoprofene and Tramadol Tramadol 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). Paracetamol+ ketoprofene+ Nefopam and Tramadol Tramadol 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). Paracetamol+ ketoprofene+Opioid delayed release and morphine Morphine Sulfate 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). Paracetamol+ ketoprofene and morphine Morphine Sulfate 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).
- Primary Outcome Measures
Name Time Method Quality of Recovery (QoR) 40 survey Day 2 score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU de Nimes
🇫🇷Nîmes, France