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Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain

Primary Purpose

Post-mastectomy Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thermal Radiofrequency neurolysis of Stellate ganglion
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-mastectomy Pain Syndrome

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female patient 20-65yrs underwent surgery for breast cancer Pain duration of more than 6 months Pain is moderate to severe pain (visual analog scale [VAS] ≥ 4 cm), Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4 Exclusion Criteria: Refusal of the patient Recent myocardial infarction Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio) Glaucoma Pre-existing counter lateral nerve palsy Severe emphysema Cardiac conduction block Local and systemic sepsis Local anatomical distortion (which may render the block technically difficult or hazardous. Psychiatric illness.

Sites / Locations

  • NCIEgypt IRB officeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stellate ganglion block with alcohol injection

thermal RF neurolysis of Stellate ganglion

Arm Description

Stellate ganglion block with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.

Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance

Outcomes

Primary Outcome Measures

Changes in VAS
assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks . A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 100 mm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).

Secondary Outcome Measures

patient satisfaction by patient satisfaction score and the analgesic concomitant medications consumption will be assessed before and 1,4,8 and 12 weeks after block
satisfaction score where 0 dissatisfied ,10 very satisfied

Full Information

First Posted
February 21, 2023
Last Updated
July 31, 2023
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05771103
Brief Title
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
Official Title
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy. Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
Detailed Description
Breast cancer is the most common cause of cancer death for women . Postmastectomy pain syndrome (PMPS) is a frequent complication of breast surgery, and is considered a chronic neuropathic pain in the side of surgery which persists more than 3 months. Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve often from surgical intervention or trauma. The stellate ganglion (SG), also known as the cervico-thoracic ganglion, is part of the sympathetic nervous system. After assessment of eligibility criteria a predetermined randomization list and will be generated using random blocks. Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy. Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice has to be 0.5 cm apart from each other . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance Group A ,The procedure will be started by placing the needle tip аntеrоlаteral to the lоngusсоlli muscle, dееp to the prеvеrtebrаlfаsсia in оrdеr tо аvоid spread along the carotid sheath, but superficial to the fascia investing the longus colli muscle (to prevent injecting into the muscle). Identifying the correct fascial plane achieved with portable ultrasound guidance thus facilitating the caudal spread of the injectate to reach the stellate ganglion at the C7-T1 level. This allowed for a more effective and stable sympathetic block with the use of a small injected volume. As an injection, we firstly used 1%-2.0 ml of lidocaine. The procedure will be continued by the injection of ethanol 50%, in quantity 1.5 ml for a lasting effect. Group B, thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-mastectomy Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block with alcohol injection
Arm Type
Active Comparator
Arm Description
Stellate ganglion block with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
Arm Title
thermal RF neurolysis of Stellate ganglion
Arm Type
Active Comparator
Arm Description
Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
Intervention Type
Device
Intervention Name(s)
thermal Radiofrequency neurolysis of Stellate ganglion
Other Intervention Name(s)
Stellate ganglion block with alcohol injection
Intervention Description
Stellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate ganglion
Primary Outcome Measure Information:
Title
Changes in VAS
Description
assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks . A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 100 mm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
Time Frame
12 WEEKS
Secondary Outcome Measure Information:
Title
patient satisfaction by patient satisfaction score and the analgesic concomitant medications consumption will be assessed before and 1,4,8 and 12 weeks after block
Description
satisfaction score where 0 dissatisfied ,10 very satisfied
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female underwent radical mastectomy because of breast cancetr
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patient 20-65yrs underwent surgery for breast cancer Pain duration of more than 6 months Pain is moderate to severe pain (visual analog scale [VAS] ≥ 4 cm), Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4 Exclusion Criteria: Refusal of the patient Recent myocardial infarction Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio) Glaucoma Pre-existing counter lateral nerve palsy Severe emphysema Cardiac conduction block Local and systemic sepsis Local anatomical distortion (which may render the block technically difficult or hazardous. Psychiatric illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
suzan adlan, lecturer
Phone
01111068300
Email
dr_s.adlan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Taher Thabet, lecturer
Phone
01225358877
Email
dr.taherthabet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suzan adlan, lecturer
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCIEgypt IRB office
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain

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