Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (Shoulder1)

Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After 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.

Study Overview

• Status: Unknown
• Conditions: Tendon Injuries
• Intervention / Treatment: Drug: Tramadol; Drug: Nefopam 20 MG/ML; Drug: Morphine Sulfate; Drug: Oxycodone 20mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: philippe cuvillon, PhD, MD; Phone Number: 33-1-4 66 68 30 50; Email: philippe.cuvillon@chu-nimes.fr
• Study Contact Backup: Name: christophe masseguin; Phone Number: 33-1-4 66 68 30 50

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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; Tramadol; Ketoprofene
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; Morphine Sulfate; Ketoprofene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery (QoR) 40 survey	score based on 200 points (minimum 40, maximum 200), 40 questions (5 points for each question)	Day 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: benjamin Garnaud, MD, CHU Nimes, Nimes University, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: opioid; surgery; analgesia; shoulder
• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Tramadol; Oxycodone; Nefopam
• Other Study ID Numbers: AOI 2017-1316-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No