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

• Sponsor: National Cancer Institute, Egypt (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04953507
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Thermal Radiofrequency; Procedure: Chemical Neurolysis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Thermal Radiofrequency Versus Chemical Neurolysis Using Perfusion Index Derived Pulse Oximeter
• Actual Study Start Date: Jul 3, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thermal Radiofrequency T2, T3 block by thermal radiofrequency lesioning at 80°c for 60-90 seconds	Procedure: Thermal Radiofrequency; Radiofrequency lesioning at level of T2, T3 using 80°c for 60-90 seconds
Active Comparator: Chemical Neurolysis T2, T3 block by chemical neurolysis using 2-3 ml of phenol in glycerin 6%	Procedure: Chemical Neurolysis; injection of 2 to 3 ml of the chemical neurolytic agent (phenol in glycerin 6%)

Outcome Measures

Primary Outcome Measures

1. Perfusion index trend [procedure time]

   measuring the change in perfusion index in the ipsilateral limb compared to the control limb

Secondary Outcome Measures

1. Visual analogue score [6 weeks]

   minimum score 0 and maximum score 10

2. Opioid consumption [6 weeks]

   total opioid consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walaa Y Elsabeeny	Cairo		Egypt	11796

Sponsors and Collaborators

• National Cancer Institute, Egypt

Investigators

• Principal Investigator: Walaa Y Elsabeeny, MD, Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walaa Youssef Elsabeeny, Lecturer of Anesthesia and Pain management, National Cancer Institute, Egypt
• ClinicalTrials.gov Identifier: NCT04953507
• Other Study ID Numbers: AP2104-50104
• First Posted: Jul 8, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 6, 2022