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 identification

• EU PAS number:
  EUPAS9215
• Study ID:
  9216
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Slovenia
• Study description:
  Background:Immediate breast reconstruction with an expander is a reasonable option for properly selected patients. After reconstruction, patients have severe postoperative pain, which responds poorly to opioids. Our 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.Methods:Altogether, 60 patients were enrolled in our study, one half in the group with wound infusion of a local anaesthetic, and the other half in the standard (piritramide) group. Parameters measured included: pain intensity (visual analogue scale), drug requirements, alertness, hospitalisation, side-effects and late complications. A p-value of < 0.05 was considered statistically significant.Results:In the recovery room, the test group reported less acute pain at rest( P=0.03) and at activity (P= 0.01), and on the day of the surgical procedure they reported less pain at activity (P= 0.003). Consumption of piritramideand metoclopramide was lower in this group (P< 0.0001), but their alertness after the surgical procedure was higher compared to the standard group (P< 0.001). After three months, the test group reported less chronic pain (P=0.01).Conclusions:After 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.
• 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:24/01/2011

Actual:24/01/2011

Data analysis start date

Planned:15/10/2012

Actual:15/10/2012

Date of final study report

Planned:17/09/2013

Actual:17/09/2013

Sources of funding

Other

More details on funding

National health insurance

Regulatory

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