Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty

April 5, 2023 updated by: Hospital Universitario Virgen Macarena

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria Carmen Gonzalez Lopez
  • Phone Number: 0034 675175531
  • Email: mcglez89@gmail.com

Study Contact Backup

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency group
Patient group that undergoes Radiofrequency of supraescapular nerve before shoulder arthroplasty surgery
Procedure: supraescapular nerve radiofrequency
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery
Active Comparator: Interscalenic braquial plexus block group
Interscalenic braquial plexus block done at the moment of the surgery.
Procedure: interescalenic braquial plexus
supraescapular nerve radiofrequency or interescalenic braquial plexus for pain control in shoulder arthroplasty surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogical scale
Time Frame: periodical measurements of pain, inmediate preoperative pain up to three months postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogical scale
Time Frame: 3 months postop. until 1 year postop
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen Macarena

Investigators

  • Principal Investigator: Jose Manuel Lopez Millan, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAP_PIH_20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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