Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04110665

Acronym

Shoulder1

Enrollment

Registered

2019-10-01

Start date

2017-09-01

Completion date

2019-09-26

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injuries

Keywords

shoulder, surgery, analgesia, opioid

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.

Interventions

DRUGTramadol

Tramadol 100 mg tablet

DRUGNefopam 20 MG/ML

120 mg for 24 hours

DRUGMorphine Sulfate

Tablet 10mg

DRUGOxycodone 20mg

release

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Evaluation of the treatment based on QoR40 survey every 20 patients

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026