NCT05771103

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

February 21, 2023

Last Update Submit

July 31, 2023

Conditions

Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 WEEKS

Secondary Outcomes (1)

  • 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

    12 weeks

Study Arms (2)

Stellate ganglion block with alcohol injection

ACTIVE COMPARATOR

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

Device: thermal Radiofrequency neurolysis of Stellate ganglion

thermal RF neurolysis of Stellate ganglion

ACTIVE COMPARATOR

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

Device: thermal Radiofrequency neurolysis of Stellate ganglion

Interventions

thermal Radiofrequency neurolysis of Stellate ganglionDEVICE

Stellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate ganglion

Also known as: Stellate ganglion block with alcohol injection
Stellate ganglion block with alcohol injectionthermal RF neurolysis of Stellate ganglion

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale underwent radical mastectomy because of breast cancetr
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCIEgypt IRB office

Cairo, 11796, Egypt

RECRUITING

Study Officials

  • suzan adlan, lecturer

    National Cancer Institute, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

suzan adlan, lecturer

CONTACT

01111068300dr_s.adlan@hotmail.com

Taher Thabet, lecturer

CONTACT

01225358877dr.taherthabet@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 16, 2023

Study Start

January 1, 2023

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)