Recruiting

Thoracic Paravertebral Block

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05711030

Conditions

Breast Neoplasms

Breast Neoplasm Female

Cancer, Breast

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Thoracic paravertebral block multiple (3) injections

Thoracic paravertebral block single injection

Study Details

Brief summary:

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.

Conditions

Breast Neoplasms

Breast Neoplasm Female

Cancer, Breast

Breast Cancer

Study ID

NCT05711030

Start date

Nov 4, 2022

Status verified date

Feb, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Thoracic paravertebral block multiple (3) injections

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.

experimental: Thoracic paravertebral block single injection

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.

Interventions

Thoracic paravertebral block multiple (3) injections

already described in arm description

Thoracic paravertebral block single injection

already described in arm description

Primary outcome measure

  • Total perioperative fentanyl (mcg) consumption [ Time Frame: Intraoperative, about 30 minutes ]
  • Total perioperative ketamine (mg) consumption [ Time Frame: Intraoperative, about 30 minutes ]

Central Contacts and Locations

Central contacts

Ariane Clairoux, MD

5142226743ariane.clairoux@umontreal.ca

Nadia Godin, RN

5142523400ngodin.hmr@ssss.gouv.qc.ca

Locations

CIUSSS de l'Est de l'Île de Montréal

Recruiting

Montréal, Quebec, Canada, H1T2M4

Contacts

Philippe PR Richebé, MD, PhD

5142523400philippe.richebe@umontreal.ca

Nadia NG Godin, RN

5142523400ngodin.hmr@ssss.gouv.qc.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 20, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-02-20.