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

NCT ID: NCT04953507

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2025-02-25

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thermal Radiofrequency

T2, T3 block by thermal radiofrequency lesioning at 80°c for 120 seconds

Group Type: EXPERIMENTAL

Thermal Radiofrequency

Intervention Type: PROCEDURE

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

Chemical Neurolysis

T2, T3 block by chemical neurolysis using 1.5 ml of phenol in saline 8% at each level

Group Type: ACTIVE_COMPARATOR

Chemical Neurolysis

Intervention Type: PROCEDURE

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

Interventions

Thermal Radiofrequency

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

Intervention Type: PROCEDURE

Chemical Neurolysis

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Walaa Youssef Elsabeeny

Assistant professor of Anesthesia and Pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Walaa Y Elsabeeny

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP2104-50104

Identifier Type: -

Identifier Source: org_study_id