AnalgesiaNCT04953507
Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Pulse Oximeter
A study testing Thermal Radiofrequency and Chemical Neurolysis in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Thermal Radiofrequency and Chemical Neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2021to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with postmastectomy pain syndrome
- ≥ Age 18 years
- ASA II-III
Who cannot join
- patient refusal
- coagulation defects
- abnormal kidney or liver functions
- local infection at site of injection
- bone metastases
- severe cardiorespiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Thermal Radiofrequency, Chemical Neurolysis
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal RadiofrequencyProcedure or surgery
Radiofrequency lesioning at level of T2 and T3 using 80°c for 120 seconds
Chemical NeurolysisProcedure or surgery
injection of 1.5 ml of the chemical neurolytic agent (phenol in saline 8%) at each level
| Study group | Role | What they receive |
|---|---|---|
| Thermal Radiofrequency | Experimental | T2, T3 block by thermal radiofrequency lesioning at 80°c for 120 seconds Receives: 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 Receives: Procedure: Chemical Neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
minimum score 0 and maximum score 10
Measured: up to 24 weeks
Secondary outcomes (2)
Perfusion index trend
measuring the change in perfusion index in the ipsilateral limb after the procedure compared to pre-procedural
Measured: procedure time
Opioid consumption
average opioid consumption
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start3 Jul 2021
- Primary completion10 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953507
- Sponsor's protocol ID
- AP2104-50104
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon reasonable request through contacting the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Thermal Radiofrequency Versus Chemical Neurolysis Using Perfusion Index Derived Pulse Oximeter
- ClinicalTrials.gov ID
- NCT04953507
- Acronym / sponsor ID
- AP2104-50104
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal Radiofrequency | Experimental | Procedure: Thermal RadiofrequencyT2, T3 block by thermal radiofrequency lesioning at 80°c for 120 seconds |
| Chemical Neurolysis | Active comparator | Procedure: Chemical NeurolysisT2, T3 block by chemical neurolysis using 1.5 ml of phenol in saline 8% at each level |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients with postmastectomy pain syndrome
- ≥ Age 18 years
- ASA II-III
Key exclusion criteria (6 listed)
- patient refusal
- coagulation defects
- abnormal kidney or liver functions
- local infection at site of injection
- bone metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal RadiofrequencyRadiofrequency lesioning at level of T2 and T3 using 80°c for 120 seconds | Procedure or surgery | Thermal Radiofrequency |
| Chemical Neurolysisinjection of 1.5 ml of the chemical neurolytic agent (phenol in saline 8%) at each level | Procedure or surgery | Chemical Neurolysis |
Primary outcome
Visual analogue score
Time frame: up to 24 weeks
minimum score 0 and maximum score 10
2 secondary outcomes
Perfusion index trend
Time frame: procedure time
Opioid consumption
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. Data will be available upon reasonable request through contacting the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walaa Y Elsabeeny, MD principal investigator
Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Radiofrequency and Chemical Neurolysis in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.