Back to resultsThe Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
Primary Purpose
Chronic Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
suprascapular nerve block
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain Syndrome focused on measuring post mastectomy pain
Eligibility Criteria
Inclusion Criteria:
- patients with post-mastectomy pain
Exclusion Criteria:
- Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.
Sites / Locations
- Tanta university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
suprascapular nerve RF
suprascapular nerve block
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
postoperative pain
assessment using visual analogue scale
Secondary Outcome Measures
shoulder movement
shoulder mobility using long arm geniometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03247842
Brief Title
The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
Official Title
The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Syndrome
Keywords
post mastectomy pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
suprascapular nerve RF
Arm Type
Active Comparator
Arm Description
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)
Arm Title
suprascapular nerve block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
suprascapular nerve block
Intervention Description
Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
Primary Outcome Measure Information:
Title
postoperative pain
Description
assessment using visual analogue scale
Time Frame
immedite postopertive
Secondary Outcome Measure Information:
Title
shoulder movement
Description
shoulder mobility using long arm geniometry
Time Frame
6 months after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
patients with cancer breast
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with post-mastectomy pain
Exclusion Criteria:
Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.
Facility Information:
Facility Name
Tanta university hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
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