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

NCT ID: NCT03494426

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-01-01

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.

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 .

Conditions

Post-Mastectomy Chronic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

interventional group

patients will receive Radiofrequency thoracic sympathectomy then will receive pregabalin ,tramadol,and tricyclic antidepressants

Group Type: EXPERIMENTAL

radiofrequency thoracic sympathectomy

Intervention Type: PROCEDURE

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.

pregabalin ,tramadol,and tricyclic antidepressants

Intervention Type: DRUG

patient will receive anti neuropathic medications

control group

patients will receive pregabalin ,tramadol,and tricyclic antidepressants

Group Type: ACTIVE_COMPARATOR

pregabalin ,tramadol,and tricyclic antidepressants

Intervention Type: DRUG

patient will receive anti neuropathic medications

Interventions

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.

Intervention Type: PROCEDURE

pregabalin ,tramadol,and tricyclic antidepressants

patient will receive anti neuropathic medications

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Madona M.NOMAN

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Essam E Abd El Hakem, MD

Role: STUDY_DIRECTOR

Assiut University

Ashraf A Mohamed, MD

Role: STUDY_DIRECTOR

Assiut University

Diab F Hetta, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Madona Misheal Boshra Noman

Asyut, , Egypt

Countries

Egypt

References

Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.

Reference Type: BACKGROUND

PMID: 10506676 (View on PubMed)

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.

Reference Type: BACKGROUND

Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 12855309 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19903919 (View on PubMed)

Steegers MA, Wolters B, Evers AW, Strobbe L, Wilder-Smith OH. Effect of axillary lymph node dissection on prevalence and intensity of chronic and phantom pain after breast cancer surgery. J Pain. 2008 Sep;9(9):813-22. doi: 10.1016/j.jpain.2008.04.001. Epub 2008 Jun 30.

Reference Type: BACKGROUND

PMID: 18585963 (View on PubMed)

Carpenter JS, Andrykowski MA, Sloan P, Cunningham L, Cordova MJ, Studts JL, McGrath PC, Sloan D, Kenady DE. Postmastectomy/postlumpectomy pain in breast cancer survivors. J Clin Epidemiol. 1998 Dec;51(12):1285-92. doi: 10.1016/s0895-4356(98)00121-8.

Reference Type: BACKGROUND

PMID: 10086821 (View on PubMed)

Cohen SP, Sireci A, Wu CL, Larkin TM, Williams KA, Hurley RW. Pulsed radiofrequency of the dorsal root ganglia is superior to pharmacotherapy or pulsed radiofrequency of the intercostal nerves in the treatment of chronic postsurgical thoracic pain. Pain Physician. 2006 Jul;9(3):227-35.

Reference Type: BACKGROUND

PMID: 16886031 (View on PubMed)

Cahana A, Van Zundert J, Macrea L, van Kleef M, Sluijter M. Pulsed radiofrequency: current clinical and biological literature available. Pain Med. 2006 Sep-Oct;7(5):411-23. doi: 10.1111/j.1526-4637.2006.00148.x.

Reference Type: BACKGROUND

PMID: 17014600 (View on PubMed)

Guo L, Kubat NJ, Nelson TR, Isenberg RA. Meta-analysis of clinical efficacy of pulsed radio frequency energy treatment. Ann Surg. 2012 Mar;255(3):457-67. doi: 10.1097/SLA.0b013e3182447b5d.

Reference Type: BACKGROUND

PMID: 22301609 (View on PubMed)

Other Identifiers

thoracic sympathectomy

Identifier Type: -

Identifier Source: org_study_id