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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Thermal Radiofrequency; Procedure: Chemical Neurolysis

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Walaa Y Elsabeeny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal Radiofrequency; T2, T3 block by thermal radiofrequency lesioning at 80°c for 120 seconds	Procedure: Thermal Radiofrequency; Radiofrequency lesioning at level of T2 and T3 using 80°c for 120 seconds
Active Comparator: Chemical Neurolysis; T2, T3 block by chemical neurolysis using 1.5 ml of phenol in saline 8% at each level	Procedure: Chemical Neurolysis; injection of 1.5 ml of the chemical neurolytic agent (phenol in saline 8%) at each level

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	up to 24 weeks

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Walaa Y Elsabeeny, MD, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2021
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AP2104-50104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon reasonable request through contacting the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No