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

NCT ID: NCT03713255

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

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.

Conditions

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Breast Cancer Acute Pain Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple (participant, care provider, investigator, outcomes assessor)

Study Groups

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PVB group

paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Group Type ACTIVE_COMPARATOR

PVB group

Intervention Type PROCEDURE

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

MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Group Type EXPERIMENTAL

MTP block group

Intervention Type PROCEDURE

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

local anesthetic infiltration subcutaneous 1% lidocaine

Group Type SHAM_COMPARATOR

Control Group

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioana Costache, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital, Ottawa Hospital Research Institute

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ioana Costache, MD

Role: CONTACT

(613) 737-8187

Facility Contacts

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Ioana Costache, MD

Role: primary

Other Identifiers

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20180259-01H

Identifier Type: -

Identifier Source: org_study_id

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