The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The investigators have developed a novel ultrasound-guided nerve block indicated primarily
for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the
internationally accepted regional anesthesia golden standard for anesthesia of the hemithorax
- but hypothetically without the risks of adverse events associated with the TPVB (i.e.
pneumothorax, risk of bleeding in the thoracic paravertebral space, random and unmanageable
epidural spread etc.). The investigators have already tested the anatomical- and block
execution hypothesis in a randomized cadaveric study, and the investigators now have
anatomical proof of concept for the functionality of the block technique. The investigators
have also conducted a small clinical pilot study with very promising results. The
investigators wish to conduct a randomized, placebo controlled and double-blind study,
comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB)
vs. placebo. The aim with this study is to investigate the efficacy of the MICB vs. placebo
in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast
cancer or ductal carcinoma in situ. The hypothesis is, that the unilateral MICB will
significantly reduce the opioid consumption during the first 24 postoperative hours and
significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side
effects.