Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

NCT04110665 | Completed Phase 4 DMC

• 2 other identifiers: Local/2017/PC-032017-A01316-47
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendon Injuries

Keywords

shoulder; surgery; analgesia; opioid

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery (QoR) 40 survey

  score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)

  Day 2

Study Arms (4)

Paracetamol+ ketoprofene and Tramadol

ACTIVE COMPARATOR

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

Paracetamol+ ketoprofene+ Nefopam and Tramadol

ACTIVE COMPARATOR

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; Drug: Nefopam 20 MG/ML

Paracetamol+ ketoprofene and morphine

ACTIVE COMPARATOR

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

Paracetamol+ ketoprofene+Opioid delayed release and morphine

ACTIVE COMPARATOR

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; Drug: Oxycodone 20mg

Interventions

Tramadol DRUG

Tramadol 100 mg tablet

Also known as: Paracetamol, Ketoprofene

Paracetamol+ ketoprofene and Tramadol; Paracetamol+ ketoprofene+ Nefopam and Tramadol

Nefopam 20 MG/ML DRUG

120 mg for 24 hours

Also known as: Paracetamol, Ketoprofene, Tramadol

Paracetamol+ ketoprofene+ Nefopam and Tramadol

Morphine Sulfate DRUG

Tablet 10mg

Also known as: Paracetamol, Ketoprofene

Paracetamol+ ketoprofene and morphine; Paracetamol+ ketoprofene+Opioid delayed release and morphine

Oxycodone 20mg DRUG

release

Also known as: Paracetamol, Ketoprofene, Morphine Sulfate

Paracetamol+ ketoprofene+Opioid delayed release and morphine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder surgery
• under general anesthesia with an nterscalenic block
• written informed consent
• age \> 18 years

You may not qualify if:

• age \< 18years
• emergency surgery
• refusal
• drug or opioid abuses

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Garnaud B, Mares O, L'hermite J, Vialles N, Gricourt Y, Lannelongue A, Lefrant JY, Cuvillon P. Multimodal oral analgesia strategy after ambulatory arthroscopic shoulder surgery: case series using adaptive therapeutic approaches by sequential analysis. J Shoulder Elbow Surg. 2021 Feb;30(2):250-257. doi: 10.1016/j.jse.2020.08.040. Epub 2020 Sep 18.

  PMID: 32950669 RESULT

MeSH Terms

Conditions

Tendon Injuries; Agnosia

Interventions

Tramadol; Acetaminophen; Nefopam; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• benjamin Garnaud, MD

  CHU Nimes, Nimes University, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of the treatment based on QoR40 survey every 20 patients

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: October 1, 2019
• Study Start: September 1, 2017
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)