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

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Procedure: Chemical Neurolysis; Procedure: Thermal Radiofrequency

• Registration Number: NCT04953507
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Study First Submitted: 2021-06-28
• Study Start: 2021-07-03
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemical Neurolysis	Chemical Neurolysis	T2, T3 block by chemical neurolysis using 2-3 ml of phenol in glycerin 6%
Thermal Radiofrequency	Thermal Radiofrequency	T2, T3 block by thermal radiofrequency lesioning at 80°c for 60-90 seconds

Primary Outcome Measures

Name	Time	Method
Perfusion index trend	procedure time	measuring the change in perfusion index in the ipsilateral limb compared to the control limb

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	6 weeks	total opioid consumption
Visual analogue score	6 weeks	minimum score 0 and maximum score 10

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt