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

NCT03494426 | Completed

• 1 other identifier: thoracic sympathectomy
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• The intensity of pain

  The intensity of pain measured by visual analogue score

  up to 3 months after the procedure

Secondary Outcomes (3)

• The changes in analgesics consumption

  1 month, 2 month and 3 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

  3 month post- procedure

Study Arms (2)

interventional group

EXPERIMENTAL

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

Procedure: radiofrequency thoracic sympathectomy; Drug: pregabalin ,tramadol,and tricyclic antidepressants

control group

ACTIVE COMPARATOR

patients will receive pregabalin ,tramadol,and tricyclic antidepressants

Drug: pregabalin ,tramadol,and tricyclic antidepressants

Interventions

radiofrequency thoracic sympathectomy 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.

interventional group

pregabalin ,tramadol,and tricyclic antidepressants DRUG

patient will receive anti neuropathic medications

control group; interventional group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Madona Misheal Boshra Noman

Asyut, 002, Egypt

Location

Related Publications (10)

• 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.

  PMID: 10506676 BACKGROUND

• 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.

  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.

  PMID: 21435953 BACKGROUND

• Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

  PMID: 12855309 BACKGROUND

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 BACKGROUND

• 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.

  PMID: 18585963 BACKGROUND

• 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.

  PMID: 10086821 BACKGROUND

• 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.

  PMID: 16886031 BACKGROUND

• 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.

  PMID: 17014600 BACKGROUND

• 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.

  PMID: 22301609 BACKGROUND

Study Officials

• Essam E Abd El Hakem, MD

  Assiut University

  STUDY DIRECTOR

• Ashraf A Mohamed, MD

  Assiut University

  STUDY DIRECTOR

• Diab F Hetta, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 7, 2020

Record last verified: 2019-07

Locations

EG (1)