Clinical study

A randomized double-blind placebo-controlled clinical trial testing the blockade on breast cancer patients 

  • Research area: Regional blockade

  • Primary investigator: Martin Vedel Nielsen

A randomized double-blind placebo-controlled clinical trial testing the blockade on breast cancer patients.

We have set up a randomized, double-blind controlled clinical trial to test our new blockade against placebo (saline) in patients who need to be mastectomized (breast removed) with concomitant reconstructive surgery. Our hypothesis is that the costotransverse blockade will reduce opioid consumption by 70% in the first 24 postoperative hours. Opioid consumption in the first 24 postoperative hours is the primary endpoint. After approval from all relevant authorities and the Good Clinical Practice unit, which continuously monitors the trial, the trial started at the end of November 2019. Thirty-six patients are needed, and we have just had number 24 with (May 2021) – the inclusion rate has unfortunately been slower than expected. We expect to have included the last patient at the beginning of 2022. Now a picture emerges of two groups in terms of opioid consumption – and it is striking to see patients with broad smiles in the awakening, relieved because the operation is over, happy to be pain-free.