Non-interventional Study Evaluating the Management of Pain Using a Technique Developed and Commonly Used by the Center, in Patients Who Underwent Arthroscopic Surgery of the Shoulder in the Outpatient Setting.

NCT04189731 | Completed

• 1 other identifier: 87RI19_0031 (BSS-CHIR)
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder surgery is performed usually under interscalene block considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. The Orthopedic Surgery Department of Clinique Chénieux has been operating patients requiring arthroscopic shoulder surgery with a short interscalene block relayed by a long suprascapular block. The main objective is to evaluate the effectiveness of this method by measuring the average pain over 3 days after the operation.

Conditions

Shoulder Pain

Keywords

Shoulder surgery; pain; suprascapular block

Outcome Measures

Primary Outcomes (3)

• Average of pain

  Score of average pain at D1, D2 and D3 by a numeric pain scale (NPS) \<4/10

  Day1

• Average of pain

  core of average pain at D2 by a numeric pain scale (NPS) \<4/10

  Day2

• Average of pain

  core of average pain at D3 by a numeric pain scale (NPS) \<4/10

  Day 3

Secondary Outcomes (7)

• Number of readmissions

  Day 7

• Number of painful peaks

  Day 0

• Analgesics consummation

  Day 1, Day 2, Day 3, Day 4 and Day 7

• Score of Pain

  Day 4, Day 7, Day 15 and Day 30

• Satisfied patient rate

  Day 30

Study Arms (1)

supra-scapular block

Patient will have a short ISB (between 2h and 4h) relayed by a supra-scapular block (SSB) long (72h) through the placement of a perineural catheter thus allowing a continuous diffusion of Naropein® by an elastomeric pump

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient in need of acromioplasty or rotator cuff surgery (ruptured cuff or calcification of the cuff) or reinsertion of the glenoid bead (Bankart intervention)

You may qualify if:

• Men, women between 18 and 70 years
• Patient in need of acromioplasty or rotator cuff surgery (ruptured cuff or calcification of the cuff) or reinsertion of the glenoid bead (Bankart intervention)
• Patient with an American Society of Anesthesiologists score (ASA) of 1 or 2

You may not qualify if:

• Patient needing shoulder surgery for other indications and open surgery
• Patient with cognitive impairment or dementia symptoms
• Patient with a BMI ≥ 35 without systemic morbidity requiring hospitalization
• Contraindication to the drugs used in the study (hypersensitivity to ropivacaine or other amide-bonded local anesthetics)
• Pregnant or lactating patient
• Patient with severe hepatic impairment
• Class III antiarrhythmic patient

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Clinique chénieux: collaborator

Study Sites (1)

Clinique Chénieux

Limoges, France

Location

MeSH Terms

Conditions

Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: November 5, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

FR (1)