The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT03247842

Collaborator

(none)

Enrollment

Location

Arms

26.2

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Syndrome	Procedure: suprascapular nerve block	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 25, 2017

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

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,

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,

Outcome Measures

Primary Outcome Measures

postoperative pain [immedite postopertive]
assessment using visual analogue scale

Secondary Outcome Measures

shoulder movement [6 months after surgery]
shoulder mobility using long arm geniometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with post-mastectomy pain

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university hospital	Cairo		Egypt

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman Abd Al-maksoud Yousef, assistant professor, Tanta University

ClinicalTrials.gov Identifier:

NCT03247842

Other Study ID Numbers:

3024/01/15

First Posted:

Aug 14, 2017

Last Update Posted:

Jun 16, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayman Abd Al-maksoud Yousef, assistant professor, Tanta University

post mastectomy pain

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Jun 16, 2020