The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zealand University Hospital
• Collaborator: Copenhagen University Hospital, Denmark
• Treatments: Ropivacaine; Sufentanil

Criteria

Inclusion Criteria:

• Scheduled for elective unilateral mastectomy and primary reconstructive (UMPR) surgery with subpectoral implant due to breast cancer and ductal carcinoma in situ

• Age 18 years or above at the date of inclusion

• Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the study.

Exclusion Criteria:

• Scheduled for elective UMPR surgery due to breast cancer and DCIS combined with simultaneous contralateral major breast surgery* (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted.

• Scheduled free flap reconstructive surgery

• Inability to cooperate

• Inability to speak, read and understand Danish

• Allergy to local anaesthetics or opioids

• Daily intake of opioids, according to the investigators decision

• Illegal drug and/or substance abuse, according to the investigators decision

• Local infection at the site of injection or systemic infection

• Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution

• Substantial co-morbidity, ASA>3

• Severe hypovolemia

• Pregnant or breastfeeding