NCT03247842

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 24, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

April 24, 2017

Last Update Submit

June 12, 2020

Conditions

Chronic Pain Syndrome

Keywords

post mastectomy pain

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    assessment using visual analogue scale

    immedite postopertive

Secondary Outcomes (1)

  • shoulder movement

    6 months after surgery

Study Arms (2)

suprascapular nerve RF

ACTIVE COMPARATOR

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

suprascapular nerve block

ACTIVE COMPARATOR

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

Interventions

suprascapular nerve blockPROCEDURE

Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,

suprascapular nerve RFsuprascapular nerve block

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients with cancer breast
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with post-mastectomy pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

August 14, 2017

Study Start

April 25, 2017

Primary Completion

September 30, 2017

Study Completion

June 30, 2019

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

EG(1)