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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494426
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Madona M.NOMAN, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-Mastectomy Chronic Pain Syndrome Procedure: radiofrequency thoracic sympathectomy Drug: pregabalin ,tramadol,and tricyclic antidepressants Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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




Primary Outcome Measures :
  1. The intensity of pain [ Time Frame: up to 3 months after the procedure ]
    The intensity of pain measured by visual analogue score


Secondary Outcome Measures :
  1. The changes in analgesics consumption [ Time Frame: 1 month, 2 month and 3 month post-procedure ]
    The changes in analgesics consumption

  2. The changes in mid-arm circumference [ Time Frame: 1 month post- procedure ]
    The changes in mid-arm circumference

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494426


Locations
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Egypt
Madona Misheal Boshra Noman
Assiut, Egypt, 002
Sponsors and Collaborators
Assiut University
Investigators
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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:
H. Hoseinzade, A. Mahmoodpoor, D. Agamohammadi, and S. Sanaie, "Comparing the effect of stellate ganglion block and gabapentin on the post mastectomy pain syndrome," Rawal Medical Journal, vol. 33, no. 1, pp. 21-24, 2008.

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Responsible Party: Madona M.NOMAN, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03494426    
Other Study ID Numbers: thoracic sympathectomy
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Pregabalin
Tramadol
Antidepressive Agents
Antidepressive Agents, Tricyclic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Opioid
Narcotics