Skip to main content
OpenTrials
Completed

NCT Number: NCT04110665

Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nimes

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

Tramadol 100 mg tablet

Other names: Paracetamol, Ketoprofene

Nefopam 20 MG/ML

Drug

120 mg for 24 hours

Other names: Paracetamol, Ketoprofene, Tramadol

Morphine sulfate

Drug

Tablet 10mg

Other names: Paracetamol, Ketoprofene

Oxycodone 20mg

Drug

release

Other names: Paracetamol, Ketoprofene, Morphine Sulfate

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: Shoulder1

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.