Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

Tendon Injuries Clinical Trial

— Shoulder1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110665
• Other study ID #: AOI 2017-1316-47
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: philippe cuvillon, PhD, MD
• Phone: 33-1-4 66 68 30 50
• Email: philippe.cuvillon[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendon Injuries

Intervention

Drug:
• Tramadol
Tramadol 100 mg tablet
• Nefopam 20 MG/ML
120 mg for 24 hours
• Morphine Sulfate
Tablet 10mg
• Oxycodone 20mg
release

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery (QoR) 40 survey	score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)	Day 2