Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain

Titre officiel

Intercostobrachial Nerve Sparing in Breast Cancer Surgery to Reduce Persistent Post-surgical Pain - an International Randomized Controlled Trial

Sommaire:

La section du nerf intercostobrachial au cours d’une chirurgie pour un cancer du sein est associée à l’apparition d’une douleur postopératoire persistante qui touche jusqu’à 60 % des patientes ayant subi une telle chirurgie. Un vaste essai définitif doit être mené pour déterminer si les techniques de préservation du nerf sont efficaces pour réduire la douleur ressentie après une chirurgie pour un cancer du sein. Si l’effet de la préservation du nerf intercostobrachial concorde avec les résultats des études d’observation, la réduction absolue des taux de douleur persistante serait considérable.L’objectif principal est de comparer l’effet de la préservation du nerf intercostobrachial à celui des soins habituels sur la prévalence et l’intensité de la douleur postopératoire persistante un an après une chirurgie pour un cancer du sein comprenant une lymphadénectomie axillaire.

Description de l'essai

Primary Outcome:

  • Persistent post-surgical pain (PPSP)
  • Moderate-to-severe PPSP
  • Biomarker Sub-Study: Cytokine Levels and PPSP
  • Biomarker Sub-Study: Cytokine Levels Pre and Post-Op
Secondary Outcome:
  • Operative Time
  • General physical functioning
  • General Mental functioning
  • Upper limb-specific physical functioning
  • Return to Work
  • Adverse Events
  • Pain Interference
  • Use of Prescription Opioids
  • Return to household activities
  • Return to leisure activities
  • Return to pre-surgical functioning
A 2016 systematic review that included 30 observational studies (n= 19,813 patients) found high quality evidence that axillary lymph node dissection (ALND) is associated with a 21% absolute risk increase of PPSP (95% CI = 13% to 29%). In many cases of breast cancer, surgery involves axillary approaches; however, preliminary evidence suggests that preservation of the intercostobrachial nerves (ICBN) may reduce the incidence of PPSP after axillary clearance. A 2014 systematic review found 3 small, single-centre randomized controlled trials (RCTs), that enrolled a total of 309 patients, and explored the effect of ICBN preservation versus sacrifice during breast cancer surgery. This review found that division of the ICBN was associated with higher risk of sensory deficits, and that nerve preservation techniques increased the median operating time by 5 minutes. Due to limitations of existing evidence, clinical practice guidelines currently provide no recommendations on whether the ICBN should be preserved during axillary lymph node dissection.A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing PPSP after breast cancer surgery involving ALND. If all the apparent effect of axillary dissection is associated with lack of ICBN preservation, the absolute reduction of rates of PPSP would be considerable. Furthermore, nerve sparing requires no specialized equipment, suggesting that scalability will be highly feasible. In addition, there is substantial evidence that neuro-inflammation as a result of neural damage leads to peripheral and central changes that can be described as peripheral and central sensitization, leading to PPSP. As such, we will be conducting a biomarker sub-study as part of the pilot program. Identification of biomarkers to correlate with the development of neuropathic pain may facilitate identification of individuals at risk for development of PPSP at an early stage. The INSPIRE trial provides an important opportunity to compare patients before and after nerve injury to further explore the association of persistent pain with cytokine biomarkers. The findings will improve our mechanistic understanding of PPSP.

Voir cet essai sur ClinicalTrials.gov

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