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NCT05785572 Clinical Trial

Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty

Post Operative Pain Clinical Trial

Official title:
Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05785572
Other study ID # DAP_PIH_20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date July 1, 2024

Study information
Verified date June 2022
Source Hospital Universitario Virgen Macarena
Contact Maria Carmen González López
Phone 0034 675175531
Email mcglez89@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

This is a randomized, double-blind trial that compares the effect in postoperative pain of pulsed radiofrecuency of the supraescapular nerve carried out at least two to four weeks before reverse total shoulder arthroplasty surgery with interscalenic braquial plexus block done at the moment of the surgery. All the patients received conventional general anaesthesia and multimodal postoperative analgesia with additional patient-controlled rescue analgesics were prescribed

Recruitment information / eligibility
Status Recruiting
Enrollment 54
Est. completion date July 1, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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 Exclusion criteria: - psychiatric illness - drug abuse. - previous surgeries. - acute traumatic pathology or ethiology different from rotator cuff arthropathy - pacemaker - infectious process

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• supraescapular nerve radiofrequency
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
• interescalenic braquial plexus
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

Locations
Country Name City State
Spain Hospital Universitario Virgen Macarena Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Visual analogical scale chronic pain after surgery. From 0 to 10, Zero means no pain and ten would be the worse pain that the paitient could feel. 3 months postop. until 1 year postop
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