Evaluation of T2, T3 Sympathectomy for Postmastectomy Pai... | NCT04953507

Studies
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Pulse Oximeter

NCT04953507

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

Jul 18, 2025Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Analgesia

Interventions

Thermal Radiofrequency
Chemical Neurolysis

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2021Actual

Primary Completion Date

Feb 10, 2025Actual

Completion Date

Feb 25, 2025Actual

First Submitted Date

Jun 28, 2021

First Submission Date that Met QC Criteria

Jul 6, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Assistant professor of Anesthesia and Pain management, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to compare the efficacy of T2, T3 sympathetic block using thermal radiofrequency versus chemical neurolysis in postmastectomy pain syndrome using perfusion index derived from pulse oximetry.

Detailed Description

Postmastectomy pain is a chronic pain condition with neuropathic nature. Several drugs and methods are used for its management. This study was designed to compare the efficacy of both thermal radiofrequency and chemical neurolysis in management of postmastectomy pain through using perfusion index derived from pulse oximetry.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermal Radiofrequency	Experimental	T2, T3 block by thermal radiofrequency lesioning at 80°c for 120 seconds	Procedure: Thermal Radiofrequency
Chemical Neurolysis	Active Comparator	T2, T3 block by chemical neurolysis using 1.5 ml of phenol in saline 8% at each level	Procedure: Chemical Neurolysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermal Radiofrequency	Procedure	Radiofrequency lesioning at level of T2 and T3 using 80°c for 120 seconds	Thermal Radiofrequency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue score	minimum score 0 and maximum score 10	up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Perfusion index trend	measuring the change in perfusion index in the ipsilateral limb after the procedure compared to pre-procedural	procedure time
Opioid consumption	average opioid consumption

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with postmastectomy pain syndrome
≥ Age 18 years
ASA II-III

Exclusion Criteria:

patient refusal
coagulation defects
abnormal kidney or liver functions
local infection at site of injection
bone metastases
severe cardiorespiratory disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walaa Y Elsabeeny		Cairo		11796	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be available upon reasonable request through contacting the corresponding author

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020728	Transurethral Resection of Prostate
D009407	Nerve Block

Ancestor Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided