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

NCT04248179 | Completed Phase 4 DMC

• 1 other identifier: ZUH-MICB-UMPR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Keywords

Postoperative Pain; Opioid Consumption; Ultrasound guided nerve block; Paravertebral Block by proxy

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption

  The primary aim of this study is total morphine consumption in the first 24 postoperative hours (data from PCA pump and the patient's medical record).

  24 hours

Secondary Outcomes (8)

• Pain intensity

  24 hours

• Morphine consumption at 4, 8, 12, 16 and 20 postoperative hours.

  20 hours

• Duration of block (time to first opioid).

  24 hours

• Patient satisfaction with application of the block.

  Immediately after application

• The degree of morphine-related side effects (PONV, itching, fatigue, etc.).

  24 hours

Study Arms (2)

Active

ACTIVE COMPARATOR

Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Ropivacaine 5mg/ml corresponding to 3 \* 10ml \* 5mg/ml Ropivacaine = 150mg Ropivacaine.

Drug: Ropivacaine injection; Drug: Sufentanil and PONV prophylaxis

Placebo

PLACEBO COMPARATOR

Preoperative Multiple-injection Costotransverse Block (MICB) with three injections of each 10ml of Sodium chloride 9mg/ml corresponding to 3 \* 10ml \* 9mg/ml Sodium chloride = 189mg Sodium chloride.

Drug: Saline 0.9%; Drug: Sufentanil and PONV prophylaxis

Interventions

Ropivacaine injection DRUG

Ropivacaine 5mg/ml

Active

Saline 0.9% DRUG

Saline 0.9%

Placebo

Sufentanil and PONV prophylaxis DRUG

30 minutes prior to emergence 0.2 μg/kg total body weight Sufentanil IV and 1 gram of paracetamol IV (if 6hrs since preoperative medicine) and 4 mg ondansetron IV (PONV prophylaxis) will be administered.

Also known as: For postoperative pain and PONV treatment in the PACU

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective unilateral mastectomy and primary reconstructive (UMPR) surgery with subpectoral implant due to breast cancer and ductal carcinoma in situ
• Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (1)

• Nielsen MV, Moriggl B, Hoermann R, Nielsen TD, Bendtsen TF, Borglum J. Are single-injection erector spinae plane block and multiple-injection costotransverse block equivalent to thoracic paravertebral block? Acta Anaesthesiol Scand. 2019 Oct;63(9):1231-1238. doi: 10.1111/aas.13424. Epub 2019 Jul 23.

  PMID: 31332775 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride; Sufentanil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jens N Børglum, PhD, MD

  Department of Anaesthesiology, Zealand University Hospital, Roskilde

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: November 29, 2019
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)