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Search / Trial NCT05711030

Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery

Launched by CIUSSS DE L'EST DE L'ÎLE DE MONTRÉAL · Feb 1, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a type of anesthesia called a thoracic paravertebral block (TPVB) for women undergoing breast cancer surgery, specifically mastectomies without lymph node removal. The researchers want to find out if a single injection of TPVB can provide the same benefits as using multiple injections. Previous studies suggest that TPVB can help reduce post-operative nausea, pain, and the time spent in the hospital, making it a potentially better option than traditional general anesthesia.

To be eligible for this trial, participants must be women aged 18 and older who are in good health (ASA status I-III) and have a body mass index (BMI) of 35 or lower. Those who have certain medical conditions, such as severe sleep apnea, significant heart or kidney issues, or who are pregnant, will not be included. If you join the trial, you will be randomly assigned to receive either a single injection or three injections of TPVB before your surgery. This study aims to make the anesthesia process easier and more comfortable for patients, while also improving overall satisfaction with their surgical experience.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • • Patients \> 18 years old with American Society of Anaesthesiologists (ASA) status I-III, BMI\<35, undergoing partial or total mastectomies without axillary lymph node dissection
  • Exclusion Criteria:
  • \< 18 years old
  • Body mass index (BMI) \> 35
  • Body weight under 50 kg
  • Obstructive sleep apnea (moderate to severe)
  • Unable to communicate with the investigators
  • Receiving anticoagulation or experiencing any bleeding disorder
  • Known allergy to local anesthetics, fentanyl or hydromorphone
  • Active infection at injection sites
  • Preexisting neurological deficit or psychiatric illness
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure (estimated glomerular filtration rate \<15 mL/ min/1.73 m2)
  • Pregnancy
  • Arrhythmia (NOL monitoring cannot be used reliably)
  • Technical inability to proceed with the blocks
  • History of chronic pain with daily opioid use during the 3 months before surgery
  • Patient refusal

About Ciusss De L'est De L'île De Montréal

Ciusss de l'Est de l'Île de Montréal is a leading healthcare organization dedicated to enhancing the health and well-being of the communities it serves. As a prominent clinical trial sponsor, Ciusss de l'Est conducts innovative research aimed at advancing medical knowledge and improving patient outcomes. With a focus on collaboration and ethical standards, the organization fosters a multidisciplinary approach to clinical research, ensuring rigorous methodologies and comprehensive patient care. Through its commitment to scientific excellence and community health, Ciusss de l'Est plays a vital role in shaping the future of healthcare in the region.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Ariane Clairoux, MD

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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