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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03247842
Other study ID # 3024/01/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2017
Est. completion date June 30, 2019

Study information

Verified date June 2020
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 30, 2019
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Tanta university hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain assessment using visual analogue scale immedite postopertive
Secondary shoulder movement shoulder mobility using long arm geniometry 6 months after surgery
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