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

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

Detailed Description
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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.

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

Conditions
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Breast Cancer, Acute Pain, Anesthesia

Intervention / Treatment
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* Procedure: PVB group
* Procedure: MTP block group
* Procedure: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVB group<br>paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL | Procedure: PVB group<br>* 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).<br>|
| Experimental: MTP block group<br>MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL | Procedure: MTP block group<br>* 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).<br>|
| Sham Comparator: control group<br>local anesthetic infiltration subcutaneous 1% lidocaine | Procedure: Control Group<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional Anesthesia, Paravertebral Block, Breast Cancer Surgery, MTP block