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Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (Shoulder1)

Primary Purpose

Tendon Injuries

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tramadol
Nefopam 20 MG/ML
Morphine Sulfate
Oxycodone 20mg
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injuries focused on measuring shoulder, surgery, analgesia, opioid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de NimesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Paracetamol+ ketoprofene and Tramadol

Paracetamol+ ketoprofene+ Nefopam and Tramadol

Paracetamol+ ketoprofene and morphine

Paracetamol+ ketoprofene+Opioid delayed release and morphine

Arm 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).

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 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).

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).

Outcomes

Primary Outcome Measures

Quality of Recovery (QoR) 40 survey
score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)

Secondary Outcome Measures

Full Information

First Posted
September 10, 2019
Last Updated
September 30, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04110665
Brief Title
Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery
Acronym
Shoulder1
Official Title
Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries
Keywords
shoulder, surgery, analgesia, opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Evaluation of the treatment based on QoR40 survey every 20 patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol+ ketoprofene and Tramadol
Arm Type
Active Comparator
Arm 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).
Arm Title
Paracetamol+ ketoprofene+ Nefopam and Tramadol
Arm Type
Active Comparator
Arm 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).
Arm Title
Paracetamol+ ketoprofene and morphine
Arm Type
Active Comparator
Arm 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).
Arm Title
Paracetamol+ ketoprofene+Opioid delayed release and morphine
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Paracetamol, Ketoprofene
Intervention Description
Tramadol 100 mg tablet
Intervention Type
Drug
Intervention Name(s)
Nefopam 20 MG/ML
Other Intervention Name(s)
Paracetamol, Ketoprofene, Tramadol
Intervention Description
120 mg for 24 hours
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
Paracetamol, Ketoprofene
Intervention Description
Tablet 10mg
Intervention Type
Drug
Intervention Name(s)
Oxycodone 20mg
Other Intervention Name(s)
Paracetamol, Ketoprofene, Morphine Sulfate
Intervention Description
release
Primary Outcome Measure Information:
Title
Quality of Recovery (QoR) 40 survey
Description
score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
philippe cuvillon, PhD, MD
Phone
33-1-4 66 68 30 50
Email
philippe.cuvillon@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
christophe masseguin
Phone
33-1-4 66 68 30 50
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
benjamin Garnaud, MD
Organizational Affiliation
CHU Nimes, Nimes University, France
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Philippe Cuvillon
First Name & Middle Initial & Last Name & Degree
Christophe Boisson
First Name & Middle Initial & Last Name & Degree
Gautier Buzancais
First Name & Middle Initial & Last Name & Degree
Jean-Yves Lefrant

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
2021

Learn more about this trial

Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

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