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

NCT04953507 | Completed

• 1 other identifier: AP2104-50104
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  minimum score 0 and maximum score 10

  up to 24 weeks

Secondary Outcomes (2)

• Perfusion index trend

  procedure time

• Opioid consumption

  up to 24 weeks

Study Arms (2)

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

Thermal Radiofrequency PROCEDURE

Radiofrequency lesioning at level of T2 and T3 using 80°c for 120 seconds

Thermal Radiofrequency

Chemical Neurolysis PROCEDURE

injection of 1.5 ml of the chemical neurolytic agent (phenol in saline 8%) at each level

Chemical Neurolysis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Transurethral Resection of Prostate; Nerve Block

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures

Study Officials

• Walaa Y Elsabeeny, MD

  Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Pain management

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 8, 2021
• Study Start: July 3, 2021
• Primary Completion: February 10, 2025
• Study Completion: February 25, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)