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.

Shoulder Pain Clinical Trial

— BSS-CHIR  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189731
• Other study ID #: 87RI19_0031 (BSS-CHIR)
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The surgery of the shoulder is usually performed under interscalene block (ISB), considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. Indeed, the ISB entails, in addition to a sensory block, a motor block often useless and important since it extends beyond the shoulder to the entire upper limb. It can also be a source of anxiety and cause the risk of compression in the limb operated because of the extended sensorimotor block. It is also responsible for a painful bounce almost constant with sometimes the very rapid installation of intense pain when the effect of the sensory block disappears. This pain can be difficult to relieve despite frequent use of opioids.

The Orthopedic and Traumatologic Surgery Department of the Clinique Chénieux has been operating patients requiring arthroscopic surgery of the shoulder according to the following technique. It involves the establishment of 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. The same day or the day after the operation, the patients return to their home and are followed by nurses.

The objective of this technique is to better manage postoperative pain, thus allowing the management of patients in outpatient surgery. A prospective non-interventional study will make it possible, in a context of common practice, to obtain data on the management of pain in operated patients and then to consider a generalization of this practice to other centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Shoulder Pain

Locations

Country	Name	City	State
France	Clinique Chénieux	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Clinique chénieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average of pain	Score of average pain at D1, D2 and D3 by a numeric pain scale (NPS) <4/10	Day1
Primary	Average of pain	core of average pain at D2 by a numeric pain scale (NPS) <4/10	Day2
Primary	Average of pain	core of average pain at D3 by a numeric pain scale (NPS) <4/10	Day 3
Secondary	Number of readmissions	Number of readmissions the first week after the operation	Day 7
Secondary	Number of painful peaks	Number of painful peaks on awakening and leaving the block on the day of the operation	Day 0
Secondary	Analgesics consummation	Amount and types of analgesics consumed / consumed non-opioid during the operation and the first week after the operation	Day 1, Day 2, Day 3, Day 4 and Day 7
Secondary	Score of Pain	Score of minimum, maximum, average pain the month before the operation and by a numeric pain scale (NPS). Scale from 0 to 10.	Day 4, Day 7, Day 15 and Day 30
Secondary	Satisfied patient rate	Satisfied patient rate determined by using a satisfaction questionnaire with 4 responses: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied	Day 30
Secondary	Number of postoperative complications	Number of postoperative complications at 3 month	Month 3
Secondary	Cartilaginous Toxicology	Cartilaginous Toxicology at 6 months and 12 months determined by radiograph of the shoulder of face in 3 rotations	Month 6 and Month 12