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

NCT04248179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

DRUG

Ropivacaine injection

Ropivacaine 5mg/ml

DRUG

Saline 0.9%

Saline 0.9%

DRUG

Sufentanil and PONV prophylaxis

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.

Sponsors & Collaborators

  • Copenhagen University Hospital, Denmark

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Jens N Børglum, PhD, MD · Department of Anaesthesiology, Zealand University Hospital, Roskilde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248179 on ClinicalTrials.gov