Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery
Breast Cancer | Cancer, Breast | Breast Neoplasms | Breast Neoplasm FemaleBackground:
Mastectomies are traditionally performed under general anesthesia (GA), often with the addition of regional anesthesia for post-operative pain relief. Thoracic paravertebral blocks (TPVB) had previously been described in the literature to be sufficient for intra-operative anesthesia as an alternative to GA. A 2021 literature review by Cochrane Library comparing paravertebral anesthesia (with or without sedation) to general anesthesia for patients undergoing oncologic breast surgery showed that TPVB could reduce post-operative nausea and vomiting (PONV), hospital stay, postoperative pain and time to ambulation. It also resulted in greater patient satisfaction compared to GA.
The aim of this study is to demonstrate the efficacy of single-injection TPVB done under ultrasound guidance for patients undergoing breast cancer surgery without axillary node dissection.
Hypothesis: Single-injection thoracic paravertebral block is non-inferior to multiple (3) injections for oncologic unilateral breast surgery anesthesia.
Methods: The current study is a prospective randomized controlled trial of patients undergoing oncologic breast surgery without axillary node dissection or immediate reconstruction. Patients will be randomized into two groups; thoracic paravertebral block (TPVB) single-injection or TPVB multiple (three) injections.
Significance/Importance: Oncologic breast surgery performed under TPVB and sedation lowers the risks of post-operative nausea and vomiting, decreases peri-operative use of narcotics, decreases pain scores at rest and on mobilization and leads to better overall patient satisfaction when compared to GA. It also leads to shorter hospital stays. Most studies use multiple injections to perform the block. Even though the risks associated with TPVB are low (3.6 per 1000 surgeries), the single-injection technique could reduce the risks even more. One injection is also easier to perform and of shorter duration, leading to greater patient tolerance and less side effects related to blocks performance duration such as vaso-vagal reactions or general discomfort. To date, no studies have compared the efficacy of single-injection paravertebral block and multiple injection techniques as the main modality of anesthesia for breast cancer surgery.
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Participation Requirements
-
Sex:
FEMALE -
Eligible Ages:
18 and up
Participation 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
Study Location
CIUSSS de l'Est de l'Île de Montréal
CIUSSS de l'Est de l'Île de MontréalMontréal, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Ciusss de L'Est de l'Île de Montréal
- Participants Required
- More Information
- Study ID:
NCT05711030