Improving pain management for breast cancer surgery using an ultrasound-guided nerve block.

Phase 1

• Conditions: Postoperative pain following mastectomy and reconstructive surgery due to breast cancer.; MedDRA version: 20.0Level: LLTClassification code 10026881Term: Mastectomy radicalSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10051042Term: Plastic surgery NOSSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001016-35-DK
• Lead Sponsor: Associate Professor, Consultant Jens Børglum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Scheduled for elective unilateral mastectomy and primary reconstructive surgery (UMPR) with subpectoral implant due to breast cancer

Age above/equal to 18 years at the date of inclusion

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Scheduled for elective UMPR surgery due to breast cancer 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 necessary for the block execution

Substantial co-morbidity, ASA>3

Severe hypovolemia

Pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We 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. Our 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. Our 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)<br>and opioid related side effects.<br>;Secondary Objective: Not applicable;Primary end point(s): The primary end point of this study is total morphine consumption in the first 24 postoperative hours.;Timepoint(s) of evaluation of this end point: 24 hours postoperative.