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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713255
• Other study ID #: 20180259-01H
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Ottawa Hospital Research Institute
• Contact: Ioana Costache, MD
• Phone: (613) 737-8187
• Email: icostache[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Breast Cancer
• Breast Neoplasms

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative quality of recovery during the first 24 hours.	Measured by the Quality of recovery (QoR-15 scale).	48 hours