Comparison of continuous local anaesthetic and systemic pain treatment after axillary lymphadenectomy in breast carcinoma patients - a prospective randomized study. (CCLAA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Clinical trial
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Pain

  Postoperative analgesia

  Pain management

  Prophylaxis of nausea and vomiting

Population studied

• Short description of the study population:
  Breast carcinoma patients receiving continuous local anaesthetic and systematic pain treatment after axillary lymphadenectomy.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast cancer patients
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  The aim of the prospective randomized study was to find out if continuous wound infusion of local anaesthetic reduces postoperative pain, consumption of opioids and the incidence of chronic pain compared to the standard intravenous piritramide analgesia after axillary lymphadenectomy in breast carcinoma patients.
• Outcomes:
  After axillary lymphadenectomy in breast carcinoma patients, wound infusion of local anaesthetic reduces acute pain and enables reduced opioid consumption, resulting in less postoperative sedation and a reduced need for antiemetic drugs.
• Data analysis plan:
  The student t-test or the Mann-Whitney U test was conducted according to the data distribution. The association between categorical variables was tested by chi2 or Fisher’s exact test, as appropriate. All comparisons were two-sided and a p-value of ≤ 0.05 was considered statistically significant.