The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery

June 12, 2020 updated by: Ayman Abd Al-maksoud Yousef, Tanta University

The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.

Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

  • Egypt
      • Cairo, Egypt
        • Tanta University Hospital

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with post-mastectomy pain

Exclusion Criteria:

  • Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: suprascapular nerve RF
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups (Figure1); forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1)
Procedure: suprascapular nerve block
Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
Active Comparator: suprascapular nerve block
and forty patients received fluoroscopically guided supra-scapular nerve injection of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
Procedure: suprascapular nerve block
Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: immedite postopertive
assessment using visual analogue scale
immedite postopertive

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder movement
Time Frame: 6 months after surgery
shoulder mobility using long arm geniometry
6 months after surgery

Collaborators and Investigators

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

Sponsor

Tanta University

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)

April 25, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3024/01/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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