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Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (Shoulder1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110665
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Philippe Cuvillon, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Evaluation 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 : September 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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




Primary Outcome Measures :
  1. Quality of Recovery (QoR) 40 survey [ Time Frame: Day 2 ]
    score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110665


Contacts
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Contact: philippe cuvillon, PhD, MD 33-1-4 66 68 30 50 philippe.cuvillon@chu-nimes.fr
Contact: christophe masseguin 33-1-4 66 68 30 50

Locations
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France
CHU de Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Philippe Cuvillon         
Sub-Investigator: Christophe Boisson         
Sub-Investigator: Gautier Buzancais         
Sub-Investigator: Jean-Yves Lefrant         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: benjamin Garnaud, MD CHU Nimes, Nimes University, France
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Responsible Party: Philippe Cuvillon, Clinical Professor, Head of Anesthesia department, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04110665    
Other Study ID Numbers: AOI 2017-1316-47
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes:
shoulder
surgery
analgesia
opioid
Additional relevant MeSH terms:
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Tendon Injuries
Wounds and Injuries
Acetaminophen
Morphine
Oxycodone
Tramadol
Nefopam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics