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

Ottawa Hospital Research Institute150 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Breast Cancer Acute Pain Anesthesia

Interventions

PVB groupPROCEDURE

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).

MTP block groupPROCEDURE

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).

Control GroupPROCEDURE

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Postoperative analgesia during the first 24 hours.

Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.

Time frame: 48 hours

Secondary Outcomes

Post-operative quality of recovery during the first 24 hours.

Measured by the Quality of recovery (QoR-15 scale).

Time frame: 48 hours

Central Contacts

Ioana Costache, MD

CONTACT

(613) 737-8187 icostache@toh.ca

Data from ClinicalTrials.gov

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