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

Not Applicable

Recruiting

• Conditions: Anesthesia; Breast Cancer; Acute Pain
• Interventions: Procedure: Control Group; Procedure: PVB group; Procedure: MTP block group

• Registration Number: NCT03713255
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2020-01-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Control Group	local anesthetic infiltration subcutaneous 1% lidocaine
PVB group	PVB group	paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL
MTP block group	MTP block group	MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-operative quality of recovery during the first 24 hours.	48 hours	Measured by the Quality of recovery (QoR-15 scale).

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada