Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery

(TPVB Trial)

Overseen by Ariane Clairoux, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ciusss de L'Est de l'Île de Montréal

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: 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.

Research Team

Ariane Clairoux, MD

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

This trial is for adults over 18 with a BMI under 35, undergoing breast cancer surgery without axillary node dissection. It's not for those with severe heart or liver disease, kidney failure, allergies to specific anesthetics, pregnant women, or individuals unable to communicate with researchers.

Inclusion Criteria

I am over 18, have an ASA status of I-III, a BMI under 35, and am getting a mastectomy without lymph node removal.

Exclusion Criteria

I have an infection where I would get injections.

Body mass index (BMI) > 35

I have moderate to severe obstructive sleep apnea.

Treatment Details

Interventions

• Thoracic paravertebral block multiple (3) injections (Procedure)
• Thoracic paravertebral block single injection (Procedure)

Trial Overview The study tests if one injection of thoracic paravertebral block (TPVB) anesthesia is as effective as three injections for breast cancer surgery. Patients are randomly assigned to either the single-injection group or the multiple-injections group.

Participant Groups

Group I: Thoracic paravertebral block single injection Experimental Treatment 1 Intervention

Patients will either be in the sitting or prone position for the block. The block will be performed with the ultrasound transducer in the sagittal position about 2.5 to 3 cm lateral to the spinous process using a caudal to cranial in-plane needle approach. The thoracic vertebral levels will be identified by finding the first rib under ultrasound guidance and counting down levels appropriately. The needle (80 mm 22-gauge Pajunk) will be introduced in-plane in a caudal to cranial direction until it punctures the costotransverse ligament. Saline in 1 ml increments will be injected to confirm correct placement of the needle tip. Injection of saline or local anesthetics deep to the costotransverse ligament will lead to an anterior displacement of the parietal pleura. For the single-injection technique, injection of 30 ml of ropivacaine 0.5% will be done at the T3-T4 paravertebral space after negative aspiration.

Group II: Thoracic paravertebral block multiple (3) injections Active Control 1 Intervention

Patients will either be in the sitting or prone position for the block. The block will be performed with the ultrasound transducer in the sagittal position about 2.5 to 3 centimeters (cm) lateral to the spinous process using a caudal to cranial in-plane needle approach. The thoracic vertebral levels will be identified by finding the first rib under ultrasound guidance and counting down levels appropriately. The needle (80 mm 22-gauge echogenic SonoPlex needle from Pajunk) will be introduced in-plane in a caudal to cranial direction until it punctures the costotransverse ligament. Saline in 1 ml increments will be injected to confirm correct placement of the needle tip. Injection of saline or local anesthetics deep to the costotransverse ligament will lead to an anterior displacement of the parietal pleura. For the 3-level technique, injections will be done at the levels of T2-T3, T3-T4, and T4-T5 with 10 ml of ropivacaine 0.5% at each level.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+