Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery

NCT05711030 | Recruiting

• 1 other identifier: 2023-3181
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Total perioperative fentanyl (mcg) consumption

  To compare the total perioperative fentanyl (mcg) consumption between both groups, using the NOL index to standardize intra-operative dosage and the BIS to standardize propofol sedation. Fentanyl will be given intraoperatively according to the NOL index and the total dose in micrograms will be recorded

  Intraoperative, about 30 minutes

• Total perioperative ketamine (mg) consumption

  To compare the total perioperative ketamine (mg) consumption between both groups, using the NOL index to standardize intra-operative dosage and the BIS to standardize propofol sedation. Ketamine might be given intraoperatively according to the NOL index (if fentanyl is not sufficient) and the total dose in milligrams will be recorded.

  Intraoperative, about 30 minutes

Secondary Outcomes (9)

• Total dose of propofol (mg) required for sedation

  Intraoperative, about 30 minutes

• Adverse events

  Intraoperative and postoperative, about 3 hours

• Level of the block using ice test preoperatively

  Intraoperative, about 30 minutes

• Postoperative pain at rest and on movement (VAS) in PACU and day surgery unit

  Postoperative, about 2 hours

• Postoperative total analgesic dose of hydromorphone (mg)

  Postoperative, about 2 hours

Study Arms (2)

Thoracic paravertebral block multiple (3) injections

ACTIVE COMPARATOR

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.

Procedure: Thoracic paravertebral block multiple (3) injections

Thoracic paravertebral block single injection

EXPERIMENTAL

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.

Procedure: Thoracic paravertebral block single injection

Interventions

Thoracic paravertebral block multiple (3) injections PROCEDURE

already described in arm description

Thoracic paravertebral block multiple (3) injections

Thoracic paravertebral block single injection PROCEDURE

already described in arm description

Thoracic paravertebral block single injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Île de Montréal

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ariane Clairoux, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane Clairoux, MD

CONTACT

5142226743; ariane.clairoux@umontreal.ca

Nadia Godin, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blocks will be performed by a different anesthesiologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: February 2, 2023
• Study Start: November 4, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)