Does a continuous local anaesthetic pain treatment after immediate tissue expander reconstruction in breast carcinoma patients more efficiently reduce acute postoperative pain - a prospective randomised study (DCLAE)

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 management

  Postoperative analgesia

  Prophylaxis of nausea and vomiting

Population studied

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

Study design details

• Main study objective:
  Aim was to evaluate if continuous wound infusion of a local anaesthetic into the surgical wound reduces postoperative pain, consumption of opioids and incidence of chronic pain compared to standard intravenous piritramide after primary breast reconstruction in breast carcinoma patients.
• Outcomes:
  Ater primary tissue expander breast reconstruction, wound infusion of a local anaesthetic significantly reduces acute pain and enables reduced opioid consumption, resulting in less postoperative sedation and reduced need for antiemetic drugs. Wound infusion of a local anaesthetic reduces chronic pain.
• Data analysis plan:
  Prior data indicated that the failure rate among controls was 0.5. If the true failure rate for experimental subjects is 0.15, 27 experimental subjects and 27 control subjects are needed to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal, with probability (power) of 0.8. The type-I error probability associated with this test of the nullhypothesis is 0.05.The Student t-test or the Mann–Whitney U-test was used according to data distribution. The association between categorical variables was tested by the chi-square test or Fisher's exact test, as appropriate. All comparisons were two-sided and a P-value <0.05 was considered statisticallysignificant.