Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (Shoulder1)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Tendon Injuries

Treatments: Drug: Tramadol; Drug: Nefopam 20 MG/ML; Drug: Oxycodone 20mg; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04110665

Local/2017/PC-03

2017-A01316-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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92 participants in 4 patient groups

Paracetamol+ ketoprofene and Tramadol

Active Comparator group

Description:

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).

Treatment:

Drug: Tramadol

Paracetamol+ ketoprofene+ Nefopam and Tramadol

Active Comparator group

Description:

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).

Treatment:

Drug: Nefopam 20 MG/ML

Drug: Tramadol

Paracetamol+ ketoprofene and morphine

Active Comparator group

Description:

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).

Treatment:

Drug: Morphine Sulfate

Paracetamol+ ketoprofene+Opioid delayed release and morphine

Active Comparator group

Description:

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).

Treatment:

Drug: Oxycodone 20mg

Drug: Morphine Sulfate