Shoulder1: Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Unknown status

CT.gov ID

NCT04110665

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tendon Injuries	Drug: Tramadol Drug: Nefopam 20 MG/ML Drug: Morphine Sulfate Drug: Oxycodone 20mg	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Evaluation of the treatment based on QoR40 survey every 20 patientsEvaluation of the treatment based on QoR40 survey every 20 patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paracetamol+ ketoprofene and 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).	Drug: Tramadol Tramadol 100 mg tablet Other Names: Paracetamol Ketoprofene
Active Comparator: Paracetamol+ ketoprofene+ Nefopam and 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).	Drug: Tramadol Tramadol 100 mg tablet Other Names: Paracetamol Ketoprofene Drug: Nefopam 20 MG/ML 120 mg for 24 hours Other Names: Paracetamol Ketoprofene Tramadol
Active Comparator: Paracetamol+ ketoprofene and morphine 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 Tablet 10mg Other Names: Paracetamol Ketoprofene
Active Comparator: Paracetamol+ ketoprofene+Opioid delayed release and morphine 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 Tablet 10mg Other Names: Paracetamol Ketoprofene Drug: Oxycodone 20mg release Other Names: Paracetamol Ketoprofene Morphine Sulfate