Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Breast Cancer; Acute Pain; Anesthesia

Treatments: Procedure: Control Group; Procedure: MTP block group; Procedure: PVB group

Study type: Interventional

Funder types: Other

Identifiers

NCT03713255

20180259-01H

Details and patient eligibility

About

This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.

Full description

Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English or French Speaking
• Scheduled for major breast surgery
• ASA physical status classification I-III
• BMI <30kg/m2

Exclusion criteria

• Prior ipsilateral breast surgery
• Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
• Contraindications to regional anesthesia
• Patient refusal of regional technique
• Chronic pain disorder
• Chronic opioid use
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

PVB group

Active Comparator group

Description:

paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Treatment:

Procedure: PVB group

MTP block group

Experimental group

Description:

MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Treatment:

Procedure: MTP block group

control group

Sham Comparator group

Description:

local anesthetic infiltration subcutaneous 1% lidocaine

Treatment:

Procedure: Control Group