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Completed

NCT Number: NCT03374423

Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves or Corresponding Dorsal Root Ganglia?

neuropathic pain can occur following any surgical procedure on the breast ..

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Key information

Conditions

Post-Mastectomy Chronic Pain Syndrome

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diab

Asyut, Assuit, 71515, Egypt

About this study

chronic pain affects the daily lives of post-surgical breast cancer patients. many of these patients were undertreated for pain and generally obtained poor pain relief.treated patients with chronic thoracic segmental pain including patients with post-mastectomy pain syndrome by radiofrequency for dorsal root ganglion reported longterm pain relief.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic post-mastectomy pain for at least 3 months post operatively.
  • patients with visual analogue scale for pain score > 4
  • patients treated with more than one line of anti-neuropathic drugs.

Exclusion criteria

  • patient refusal.
  • coagulopathy.
  • chest and back deformity.
  • infection at the introduction site of the needle .

Treatment and study plan

Radiofrequency

Procedure

The procedure will be done under propofol sedation, under fluoroscopic guidance. The image intensifier will be rotated in a cephalo-caudal direction until the endplates of the thoracic vertebrae are aligned and the transverse processes became discernable from the ribs.

For the intercostal nerve group, the radiofrequency needle 10 cm with 10 ml active tip will then inserted to contact the lower edge of the transverse process of (T2-T5), the needle is walked off to obtain sensory stimulation between 0.3-0.6 mv and motor stimulation less than 1.2 mv .five cycle of pulsed radiofrequency will be delivered.

Primary outcomes

  1. The intensity of pain

    Time frame: 1 month , 2 month and 3 month post-procedure

    A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the intensity of pain. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left handend of the line to the point that the patient marks.

    Scoring and interpretation : using a ruler, score is determined by measuring the distance(mm) on the10 cm line between the "no pain" anchor and the patient's mark ,providing a range of scores from (0_100).

    A higher score indicates greater pain intensity. the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) .

Secondary outcomes

  1. The analgesics consumption

    Time frame: 1 month , 2 month and 3 month post-procedure

    The change in analgesics consumption

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Radiofrequency for Chronic Post-mastectomy Pain: is it Better to Target Intercostal Nerves (T2-T5) or Their Corresponding Dorsal Root Ganglia?

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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