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NCT04953507 Clinical Trial

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

Analgesia Clinical Trial

Official title:
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Thermal Radiofrequency Versus Chemical Neurolysis Using Perfusion Index Derived Pulse Oximeter

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04953507
Other study ID # AP2104-50104
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 3, 2021
Est. completion date December 2024

Study information
Verified date January 2024
Source National Cancer Institute, Egypt
Contact Walaa Y Elsabeeny, MD
Phone 01007798466
Email walaa.elsabeeny@nci.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Thermal Radiofrequency
Radiofrequency lesioning at level of T2, T3 using 80°c for 60-90 seconds
• Chemical Neurolysis
injection of 2 to 3 ml of the chemical neurolytic agent (phenol in glycerin 6%)

Locations
Country Name City State
Egypt Walaa Y Elsabeeny Cairo

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perfusion index trend measuring the change in perfusion index in the ipsilateral limb compared to the control limb procedure time
Secondary Visual analogue score minimum score 0 and maximum score 10 6 weeks
Secondary Opioid consumption total opioid consumption 6 weeks
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