Shoulder PainBSS-CHIRNCT04189731
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.
An observational study of Shoulder Pain, run by University Hospital, Limoges at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2020to 27 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Shoulder Pain
- Keywords
- Shoulder surgery, pain, suprascapular block
- Medical subject headings
- Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of pain
Score of average pain at D1, D2 and D3 by a numeric pain scale (NPS) <4/10
Measured: Day1
Average of pain
core of average pain at D2 by a numeric pain scale (NPS) <4/10
Measured: Day2
Average of pain
core of average pain at D3 by a numeric pain scale (NPS) <4/10
Measured: Day 3
Secondary outcomes (7)
Number of readmissions
Number of readmissions the first week after the operation
Measured: Day 7
Number of painful peaks
Number of painful peaks on awakening and leaving the block on the day of the operation
Measured: Day 0
Analgesics consummation
Amount and types of analgesics consumed / consumed non-opioid during the operation and the first week after the operation
Measured: Day 1, Day 2, Day 3, Day 4 and Day 7
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.
Measured: Day 4, Day 7, Day 15 and Day 30
Satisfied patient rate
Satisfied patient rate determined by using a satisfaction questionnaire with 4 responses: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied
Measured: Day 30
Number of postoperative complications
Number of postoperative complications at 3 month
Measured: Month 3
Cartilaginous Toxicology
Cartilaginous Toxicology at 6 months and 12 months determined by radiograph of the shoulder of face in 3 rotations
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start5 Nov 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique chénieux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189731
- Sponsor's protocol ID
- 87RI19_0031 (BSS-CHIR)
- Acronym
- BSS-CHIR
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04189731
- Acronym / sponsor ID
- BSS-CHIR / 87RI19_0031 (BSS-CHIR)
- Conditions
- Shoulder Pain
- Keywords
- Shoulder surgery, pain, suprascapular block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Clinique chénieux
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average of pain
Time frame: Day1
Score of average pain at D1, D2 and D3 by a numeric pain scale (NPS) <4/10
Average of pain
Time frame: Day2
core of average pain at D2 by a numeric pain scale (NPS) <4/10
Average of pain
Time frame: Day 3
core of average pain at D3 by a numeric pain scale (NPS) <4/10
7 secondary outcomes
Number of readmissions
Time frame: Day 7
Number of painful peaks
Time frame: Day 0
Analgesics consummation
Time frame: Day 1, Day 2, Day 3, Day 4 and Day 7
Score of Pain
Time frame: Day 4, Day 7, Day 15 and Day 30
Satisfied patient rate
Time frame: Day 30
Number of postoperative complications
Time frame: Month 3
Cartilaginous Toxicology
Time frame: Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average of pain (time frame: Day1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.