NCT04110665

Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tendon Injuries

Interventions

Type	Name	Description
DRUG	Tramadol	Tramadol 100 mg tablet
DRUG	Nefopam 20 MG/ML	120 mg for 24 hours
DRUG	Morphine Sulfate	Tablet 10mg
DRUG	Oxycodone 20mg	release

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-09-26
• Completion: 2019-09-26
• First posted: 2019-10-01
• Last updated: 2025-12-16

Locations

1 site across 1 country: France