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

Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Acute Pain; Anesthesia
• Intervention / Treatment: Procedure: PVB group; Procedure: MTP block group; Procedure: Control Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ioana Costache, MD; Phone Number: (613) 737-8187; Email: icostache@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • The Ottawa Hospital
      • Contact: Ioana Costache, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVB group; paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL	Procedure: PVB group; Patients in this group will receive preoperative ultrasound-guided thoracic paravertebral block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Experimental: MTP block group; MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL	Procedure: MTP block group; Patients in this group will receive preoperative ultrasound-guided mid-point transverse process to pleura block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Sham Comparator: control group; local anesthetic infiltration subcutaneous 1% lidocaine	Procedure: Control Group; Patients in this group will receive preoperative ultrasound-guided sham block with subcutaneous local anesthetic injection using lidocaine 1%, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesia during the first 24 hours.	Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative quality of recovery during the first 24 hours.	Measured by the Quality of recovery (QoR-15 scale).	48 hours

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Ioana Costache, MD, Ottawa Hospital, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Breast Cancer Surgery; Paravertebral Block; MTP block
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Acute Pain
• Other Study ID Numbers: 20180259-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No