Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery
1 other identifier
interventional
54
1 country
1
Brief Summary
The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedApril 7, 2023
June 1, 2022
2 years
March 15, 2023
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analogical scale
Postoperative acute pain measurement. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel.
periodical measurements of pain, inmediate preoperative pain up to three months postoperative
Secondary Outcomes (1)
Visual analogical scale
3 months postop. until 1 year postop
Study Arms (2)
Radiofrequency group
EXPERIMENTALPatient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery
Interscalenic braquial plexus block group
ACTIVE COMPARATORInterscalenic braquial plexus block done at the moment of the surgery.
Interventions
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
Eligibility Criteria
You may qualify if:
- Over 18 y.o.
- Cronic pain (more than 3 months) due to rotator cuff arthropathy
- VAS higher than 4
- Decrease Constant score
- Conservative treatment (physiotherapy and NSAIs) unsuccessful
You may not qualify if:
- psychiatric illness
- drug abuse.
- previous surgeries.
- acute traumatic pathology or ethiology different from rotator cuff arthropathy
- pacemaker
- infectious process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Manuel Lopez Millan
Hospital Universitario Virgen Macarena
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Double blind trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
March 27, 2023
Study Start
July 1, 2021
Primary Completion
July 1, 2023
Study Completion
July 1, 2024
Last Updated
April 7, 2023
Record last verified: 2022-06