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

Study identification

• EU PAS number:
  EUPAS9209
• Study ID:
  9210
• Official title and acronym:
  Comparison of continuous local anaesthetic and systemic pain treatment after axillary lymphadenectomy in breast carcinoma patients - a prospective randomized study. (CCLAA)
• DARWIN EU® study:
  No
• Study countries:
  Slovenia
• Study description:
  BACKGROUND:Acute pain after axillary lymphadenectomy is often related mainly to axillary surgery. 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.METHODS:Altogether 60 patients were enrolled in the prospective randomized study, half in wound infusion of local anaesthetic and half in the standard (piritramide) group.RESULTS:In the recovery room and on the first day after surgical procedure, the wound infusion of local anaesthetic group reported less acute and chronic pain, a lower consumption of piritramide and metoclopramide, but their alertness after the surgical procedure was higher compared to the standard group.CONCLUSIONS: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. After wound infusion of local anaesthetic there is a statistical trend for reduction of chronic pain.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute of Oncology Slovenia

Study timelines

Date when funding contract was signed

Planned:15/06/2010

Actual:15/06/2010

Study start date

Planned:01/12/2010

Actual:01/12/2010

Data analysis start date

Planned:09/12/2011

Actual:09/12/2011

Date of final study report

Planned:25/09/2012

Actual:25/09/2012

Sources of funding

Other

More details on funding

National health insurance

Regulatory

• Was the study required by a regulatory body?:
  No