Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study

January 6, 2020 updated by: Madona M.NOMAN, Assiut University
Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer, The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate. Continues Radiofrequency lesioning has been reported as treatment for several chronic pain conditions.The concept that the clinical effect of RF was caused by formation of heat had not been challenged. Thermocoagulation of nerve fibers would interfere with the conduction of nociceptive stimuli and pain would be relived. Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome .It offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment for breast cancer including radical mastectomy, modified radical mastectomy,and segmental mastectomy (lumpectomy) . The pain is distributed in the anterior chest, axilla, and medial and posterior parts of the arm . This pain can be sufficiently severe enough to interfere with sleep and performance of daily activities.

Patients may develop an immobilized arm, which can lead to severe lymph edema, frozen shoulder syndrome, and complex regional pain syndrome. PMPS can result from surgical damage to the intercostobrachial nerve( the lateral cutaneous branch of the second intercostal nerve) that is often resected at mastectomy .

The etiology of persistent pain after mastectomy is unclear, although it is likely multifactorial and may be partially neuropathic in nature . Previous reports of PMPS have suggested a limited number of potential risk factors, which are inconsistent among studies . While surgical factors, including more extensive surgery (mastectomy), axillary lymphnode dissection, and reconstruction have been postulated as important risk factors for chronic pain, many studies do not support this association. Adjuvant treatment, such as radiation, chemotherapy, and hormonal therapy, has also been occasionally associated with persistent pain .

Among demographic factors, younger age correlates with increased incidence of persistent pain in some studies but not others .

The antineuropathic medications (antidepressants and anticonvulsants) are disappointing and have low success rate, also have multiple drawbacks , specifically excessive sedation that affects daily life activities of those patients .

Radiofrequency has been used for interruption of the sympathetic chain to treat intractable pain in the sacral pelvic region or for management of visceral pain and on complex regional pain syndrome.

Radiofrequency has the advantage over surgical resection , in that it is more selective and may cause fewer complications.

Thoracic sympathectomy has been done for many painful conditions that includes complex regional pain syndrome , neuropathic pain of upper limb and it has been done for vasospastic diseases such as Raynaud's phenomenon it offers the benefit over stellate ganglion block as it blocks the Kuntz fibers that connect to the brachial plexus roots without passing through stellate ganglion .

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 002
        • Madona Misheal Boshra Noman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with chronic post-mastectomy pain for at least 6 month post-operative
  • Patients with VAS ≥ 5
  • Patients on pregabalin dose ≥ 150 mg daily
  • Patients treated with more than one line of anti-neuropathic drugs [e.g. pregabalin+(tricyclic antidepressants or selective serotonin reuptake inhibitors ) or pregabalin+ tramadole]
  • Lymphedema of the upper limb

Exclusion Criteria:

  • Patient refusal
  • Coagulopathy
  • Chest and back deformity hindering procedure impossible
  • Infection at the introduction site of the needle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional group
patients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants
Procedure: radiofrequency thoracic sympathectomy

Under fluoroscopic guidance thoracic sympathectomy will be done as follow

  1. antroposterior view of upper thoracic vertebrae ,cephalo-caudal adjustment of C - arm until aliment of endplates of T2 and T3
  2. oblique view 20 degree under tunnel view RF 10cm 20G 1mm active tip needle is introduced intimately related to vertebral margin
  3. the depth of the needle will be determined under lateral fluoroscopic view the needle is advanced step by step hugging the lateral vertebra l margin until the tip of the needle situated at the middle of the vertebral body . RF lesion 2min 80c will be done and needle is rotated 90 degree on both sides and another two lesions will be done at the end of the procedure 2ml of lidocaine and 20mg of triamcinolone will be injected at each level Post procedure analgesic protocol consisted of either increase or decrease, according to intensity of pain by 50 mg pregabalin and 50 mg tramadole and 25 mg tryptazole, individualized for each patient.
Drug: pregabalin ,tramadol,and tricyclic antidepressants
patient will receive anti neuropathic medications
Active Comparator: control group
patients will receive pregabalin ,tramadol,and tricyclic antidepressants
Drug: pregabalin ,tramadol,and tricyclic antidepressants
patient will receive anti neuropathic medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain
Time Frame: up to 3 months after the procedure
The intensity of pain measured by visual analogue score
up to 3 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in analgesics consumption
Time Frame: 1 month, 2 month and 3 month post-procedure
The changes in analgesics consumption
1 month, 2 month and 3 month post-procedure
The changes in mid-arm circumference
Time Frame: 1 month post- procedure
The changes in mid-arm circumference
1 month post- procedure
The changes in post-menopausal hot flashes if it was a pre-procedure complaint
Time Frame: 3 month post- procedure
The changes in post-menopausal hot flashes if it was a pre-procedure complaint
3 month post- procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Essam E Abd El Hakem, MD, Assiut University
  • Study Director: Ashraf A Mohamed, MD, Assiut University
  • Study Director: Diab F Hetta, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thoracic sympathectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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